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79 Study Matches

Phase 1b Study of PD-0332991 in Combination With T-DM1(Trastuzumab-DM1)

Standard of care: Treatment with Trastuzumab Experimental: 21-Day Cycle of Combination therapy with T-DM1 intravenously on Day 1 and oral PD-0332991 on Days 5-18 Study Design and Methodology: This is a phase 1B inter-patient dose escalation study of PD-0332991 in combination with T-DM1 in patients with recurrent or metastatic HER2-positive breast cancer after prior trastuzumab or other HER2-directed therapies. The subjects will be administered T-DM1 by intravenous infusion at 3.6 mg/kg for 90 minutes on day 1 of each 21 day cycle. Infusion timing may vary from 30-90 minutes depending on how well the subject tolerates the treatment. A standard 3+3 trial design will be used for PD-0332991 dose escalation cohorts.The dosing of PD-0332991 will be divided into 3 cohorts, the subjects will receive PD-0332991 on days 5-18 of each 21 day cycle. Cohort 1 : PD-0332991 - 100 mg daily (oral) Cohort 2 : PD-0332991 - 150 mg daily (oral) Cohort 3 : PD-0332991 - 200 mg daily (oral) The 3+3 design entails that if one patient out of the first three patients has a DLT, up to three additional patients will be entered at that dose level Treatment cycles will continue until disease progression or withdrawal from study.
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Barbara Haley
30339
All
18 Years to 90 Years old
Phase 1
This study is NOT accepting healthy volunteers
NCT01976169
STU 042013-042
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Inclusion Criteria:

• 1.All subjects must be informed about the study and have signed a current IRB (Institutional Review Board) approved informed consent. 2. All subjects must have recurrent or metastatic HER2-positive breast cancer. diagnosed by biopsy. 3. All subjects must have previously received trastuzumab or other HER2 targeted therapies. 4.Tumor must be HER2-positive and RB-proficient. RB (Retinoblastoma protein)-proficiency is determined by tumor biopsy demonstrating RB normal and p16in4a low by immunohistochemistry. RB proficiency means that there is an intact RB pathway indicative of responsiveness to PD-0332991. RB staining is scored on an absent (no nuclear staining), weak (nuclear staining less than observed in endothelial cells and stromal cells surrounding the tumor), positive (nuclear staining at or above surrounding tissue) (0, 0.5, 1 respectively). P16ink4a is a routine clinical stain that is scored using absent, weak, positive, strong (0,1,2,3 respectively). Tumors will be scored using [p16]/[RB], where a score of less than 3 is required for inclusion. RB loss is expected to occur in less than 15% of cases. 5. Subjects must have a performance status of ≤ 2 on the ECOG (Eastern Cooperative Oncology Group)Performance scale. 6. Subjects must have bilirubin <1.5 mg/dl, transaminases <2.5x upper limit of normal, albumin >3gm/dl, creatinine <1.3mg/dl, adequate cardiac reserve (EF>50%), ANC (Absolute neutrophil count) >1,000/mcL (microliter), and Platelets >100,000/mcL. 7. Must be willing to be treated at the University of Texas Southwestern Hospital, University of Pennsylvania and affiliated clinics. 8. Subjects must be willing to use an approved form of birth control while on this study and for 90 days after completion. 9. Age > 18 years. 10. Subject must be able to swallow capsules and have no surgical or anatomic condition that will preclude the subject from swallowing and absorbing oral medications on an ongoing basis.
Exclusion Criteria:

• 1. Chemotherapy, radiotherapy or hormonal therapy within 3 weeks ( 6 weeks for nitrosoureas, mitomycin C or bevacizumab), or who have not recovered from the adverse events to < grade 2 due to previous agents administered more than 4 weeks prior to Study Day 1. 2. Subjects less than 4 weeks post major surgery. 3. Known active CNS metastases or carcinomatous meningitis. Subjects with CNS (Central Nervous System) metastases including brain metastases who have completed a course of radiotherapy are eligible for the study provided they are clinically stable. However, oral corticosteroids for control of CNS symptoms are not allowed. 4. Known documented or suspected hypersensitivity to the components of the study drug(s) or analogs. 5. Uncontrolled systemic illness, including but not limited to ongoing or active infection. 6. Symptomatic congestive heart failure, unstable angina pectoris, stroke or myocardial infarction within 3 months. 7. Baseline neuropathy >grade 1. 8. Known positive for human immunodeficiency virus (HIV). Baseline HIV screening is not required. 9. Pregnant or breast-feeding subjects. 10. Subjects who are unable or unwilling to abide by the study protocol or to cooperate fully with the investigator or designee.
Drug: PD-0332991 and T-DM1
Advanced Breast Cancer, Breast - Female
Breast Cancer, Advanced Breast Cancer
UT Southwestern; Children’s Health
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NIMBUS: Nivolumab Plus Ipilimumab in Metastatic Hypermutated HER2-negative Breast Cancer

This research study is studying a drug combination of nivolumab and ipilimumab as a possible treatment for hypermutated HER2 negative breast cancer. The drugs involved in this study are: - Nivolumab (Opdivo ®) - Ipilimumab (Yervoy ®)
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Sangeetha Reddy
188773
All
18 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT03789110
STU-2019-0804
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Inclusion Criteria:

• Participants must have histologically or cytologically confirmed invasive breast cancer, with metastatic disease. Participants without pathologic or cytologic confirmation of metastatic disease should have unequivocal evidence of metastasis from physical examination or radiologic evaluation.
• Breast cancer must be HER2-negative by IHC or non-amplified as determined by the current ASCO-CAP criteria. If patient has more than one histological result, the most recent one will be usedfor inclusion. Participants may be ER/PR positive or negative.
• Patients must harbor tumors with total mutational burden (TMB) of at least 9 mutations per megabase assessed by a cancer-gene panel containing more than 300 genes, and performed in a CLIA verified laboratory. Tests like Foundation One, Oncopanel (DFCI), or IMPACT (MSKCC) are acceptable for including patients on this trial.
• Participants must have measurable disease by RECIST version 1.1.
• Participants must agree to undergo a research biopsy, if tumor is safely accessible, at baseline and at day 29 cycle 1 (+14 scheduling window). Previously collected archival tissue will be obtained on all participants. Participants for whom newly-obtained samples cannot be provided (e.g. inaccessible or participant safety concern) may submit an archived specimen (block or if not possible, 20 unstained slides).
• Prior chemotherapy: Participants may have received 0-3 prior chemotherapeutic regimens for metastatic breast cancer and must have been off treatment with chemotherapy for at least 14 days prior to study treatment initiation.
• Patients with hormone receptor positive breast cancer must have progressed on at least one prior line of endocrine therapy in the metastatic setting or have disease recurrence while on adjuvant endocrine therapy.
• Participants should also be adequately recovered from acute toxicities of prior treatment, with the exception of alopecia and peripheral sensory neuropathy.
• Prior biologic therapy: Patients must have discontinued all biologic therapy at least 14 days prior to study treatment initiation.
• Prior radiation therapy: Patients may have received prior radiation therapy in either the metastatic or early-stage setting. Radiation therapy must be completed 14 days prior to study treatment initiation.
• In all cases, there must be no ongoing complications from prior radiotherapy.
• The subject is ≥18 years old.
• ECOG performance status ≤1(Karnofsky ≥70%, see Appendix A).
• Participants must have normal organ and marrow function as defined below:
• absolute neutrophil count ≥1,000/mcL
• platelets ≥100,000/mcL
• hemoglobin ≥ 8 g/dl
• total bilirubin ≤1.5 × institutional upper limit of normal (ULN) (or ≤ 2.0 x ULN in patients with documented Gilbert's Syndrome)
• AST(SGOT)/ALT(SGPT) ≤2.5 × institutional ULN or (≤ 3 × institutional ULN for participants with documented liver metastases)
• creatinine ≤1.5 × institutional ULN OR creatinine clearance ≥ 40 mL/min (using Cockcroft-Gault formula) for participants with creatinine levels above institutional ULN.
• Female subjects of childbearing potential must have a negative pregnancy test (serum or urine) at screening.
• Childbearing potential is defined as: participants who have not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause) and has not undergone surgical sterilization (removal of ovaries and/or uterus).
• Female and male participants of childbearing potential must agree to use an adequate method of contraception. For women, contraception is required starting with the first dose of study medication through 150 days (5 months) after the last dose of study medication. For men who are sexuall active with women of childbearing potential, contraception is required starting with the first dose of study medication for a period of 7 months after the last dose of nivolumab. Examples of contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male sterilization, established and proper use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not acceptable methods of contraception.
• Participants on bisphosphonates may continue receiving bisphosphonate therapy during study treatment. Initiation of bisphosphonate or RANKL agent is allowed on study.
• The participant is capable of understanding and complying with the protocol and has signed the informed consent document.
Exclusion Criteria:

• Major surgery within 2 weeks before the first dose of study treatment.
• Concurrent administration of other anti-cancer therapy within 14 days of starting protocol therapy and during the course of this study.
• The participant has received another investigational agent within 14 days of the first dose of study drug.
• Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) antibody.
• Known brain metastases that are untreated, symptomatic, or require therapy to control symptoms. Participants with a history of treated central nervous system (CNS) metastases are eligible. Treated brain metastases are defined as those having no evidence of progression for ≥ 2 weeks after treatment, and no ongoing requirement for corticosteroids, as ascertained by clinical examination and brain imaging (magnetic resonance imaging or CT scan) completed during screening. Subject must be either off corticosteroids, or on a stable or decreasing dose of ≤ 10 mg daily (or equivalent) for at least 7 days prior to first study treatment. Treatment for brain metastases may include whole brain radiotherapy, radiosurgery, or a combination as deemed appropriate by the treating physician. Participants with CNS metastases treated by neurosurgical resection or brain biopsy performed within 28 days before study treatment initiation will be excluded.
• The subject has uncontrolled, significant intercurrent or recent illness. Individuals with a history of different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 3 years or are deemed by the investigator to be at low risk for recurrence of that malignancy.
• Participant has an active infection requiring IV antibiotics at initiation of study therapy.
• Patient has a medical condition that requires chronic systemic steroid therapy or on any other form of immunosuppressive medication. For example, participants with autoimmune disease that requires systemic steroids or immunosuppression agents should be excluded. Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
• Subjects with current pneumonitis, or requiring supplementary O2 therapy.
• The participant is known to be positive for human immunodeficiency virus (HIV), HepBsAg, or HCV RNA. HIV-positive participants on combination antiretroviral therapy are ineligible
• Participants with any other active malignancy requiring concurrent intervention.
• Known hypersensitivity to any of the components of ipilimumab or nivolumab.
• The participant has received a live vaccine within 28 days prior to the first dose of trial treatment and while participating in the trial. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster, yellow fever, rabies, BCG, and typhoid vaccine. The use of the inactivated seasonal influenza vaccine (Fluzone®) is allowed.
• The participant is pregnant or breastfeeding.
Drug: Nivolumab, Drug: Ipilimumab
Breast Cancer, Breast - Female
Breast Cancer
UT Southwestern; Children’s Health
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Breast-Conserving Surgery and Radiation Therapy in Patients With Multiple Ipsilateral Breast Cancer

RATIONALE: Breast-conserving surgery is a less invasive type of surgery for breast cancer and may have fewer side effects and improve recovery. Radiation therapy uses high-energy x rays to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial studies how well breast-conserving surgery and radiation therapy work in treating patients with multiple ipsilateral breast cancer
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Ann Leitch
14231
Female
40 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT01556243
STU 082012-028
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Registration
Inclusion Criteria:
1. Age ≥ 40 years per National Comprehensive Cancer Network (NCCN) recommendations for breast conservation. 2. Life Expectancy of at least 5 years, excluding diagnosis of breast cancer (Comorbid conditions should be taken into consideration, but breast cancer diagnosis is not a consideration) 3. Female Gender
•Men are excluded from this study. Male breast cancer is a rare event. Men are rarely candidates for breast conservation surgery due to small breast size. Men are less likely to be candidates for breast conservation surgery if found to have MIBC. Men are rarely candidates for breast conservation surgery due to small breast size. Men are less likely to be candidates for breast conservation surgery if found to have MIBC. 4. Foci of Breast Cancer 4.1 Upon clinical exam and pre-operative imaging by mammogram +/- MRI, two or three foci of biopsy proven breast cancer separated by > 2 cm of normal breast tissue. 4.2 Foci must include at least one focus of invasive breast carcinoma with another focus of either invasive breast carcinoma or ductal carcinoma in situ (DCIS). No more than 2 quadrants with biopsy proven breast cancer. 4.3 Note: The shortest distance between lesions must be reported on mammogram +/- MRI and eligibility criteria must be met on both, if both are obtained. 4.4 Note: Patient is eligible for study if lesion is not visualized on all imaging modalities (i.e., any of the lesion(s) is/are visualized on MRI but not on mammogram OR visualized on mammogram but not on MRI). 4.5 Ultrasound cannot be used to determine patient eligibility; eligibility to be determined by bilateral mammogram +/- MRI only. 4.6 Fine needle aspirate of the second or third lesion to document malignancy is allowed if the first focus is shown to be invasive by core needle biopsy. 4.7 Patient may remain on study if, upon pathological assessment, two or three lesions identified on pre-operative imaging represent one contiguous lesion. 5. Patients may be registered AFTER surgery and PRIOR TO radiation therapy if either of the criteria is met: 5.1 An area of atypia > 2cm from the index lesion excised at the time of cancer operation is upgraded to DCIS or invasive carcinoma thereby identifying MIBC. OR 5.2 Patient underwent resection of two or three foci of malignancy by breast conservation surgery with a minimum of one invasive focus of breast cancer and a minimum of 2 cm of normal breast tissue between the lesions on final pathology. 6. Mammogram Imaging
•Bilateral mammogram ≤ 90 days prior to date of surgery. 6.1 Note: For patients undergoing more than 1 breast operation, this is the date of the first breast surgery for breast cancer treatment. 7. Staging of Cancer
•cN0 or cN1 disease 8. ECOG Performance Status (PS)
•0, 1, or 2. 9. Ability to Complete Questionnaires
•Ability to complete questionnaire(s) by themselves or with assistance 10. Ability to Provide Written Informed Consent 11. Willing to Return to Enrolling Institution
•Willing to return to enrolling institution for follow-up during the Active Monitoring Phase (the active treatment and observation portions) of the study. Patients are encouraged to return to the enrolling institution; however, patients may receive radiation therapy at a different institution other than the enrolling institution. Registration
Exclusion Criteria:
1. Pregnancy, Nursing and Requirement for Contraception
•Pregnant women, nursing women and women of childbearing potential who are unwilling to employ adequate contraception (as determined by the treating physician) are excluded from participation. This study involves radiation therapy (WBI) that has known genotoxic, mutagenic and teratogenic effects. 2. Size of Single Focus of Disease on Preoperative Imaging
•Largest single focus of disease > 5 centimeters by either mammogram or MRI or both. Note: Measurement of the largest single focus should include any satellite lesions within 1 centimeter of the index lesion. 3. Prior Staging Procedure
•Surgical axillary staging procedure prior to first definitive breast operation. Note: FNA or core needle biopsy of axillary node is permitted. 4. Evidence of Metastatic Disease
•Clinical or radiographic evidence of metastatic disease 5. Prior History of Breast Cancer
•Prior history of ipsilateral breast cancer [DCIS, LCIS (lobular cancer in situ) or invasive] 6. Staging of Cancer
•cNX, cN2, or cN3 disease 7. Breast Implants
•Breast implants at time of diagnosis. Note: Patients who have had implants previously removed prior to diagnosis are eligible. 8. Systemic Illnesses or Concurrent Disease
•Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would interfere significantly with whole breast irradiation (such as connective tissue disorders, lupus, scleroderma). 9. Uncontrolled Intercurrent Illness
•Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. 10. Bilateral Breast Cancer
•Prior or current LCIS, DCIS or invasive breast cancer in the opposite breast (i.e., bilateral disease is not allowed). 11. Disallowed Prior Treatments
•Treatment including radiation therapy, chemotherapy, biotherapy, hormonal therapy for this cancer prior to surgery (i.e., any neoadjuvant chemotherapy or endocrine therapy is not allowed). Patients who undergo surgical resection with breast conservation and then are treated with adjuvant systemic therapy are eligible to enroll prior to the start of radiotherapy. 12. Partial Breast Radiation
•Planned partial breast radiation. 13. Known BRCA Mutations
•Patients with known BRCA mutations. Patients who are not tested or whose testing result is not returned at the time of registration are not excluded from registering to this study. 14. Other Active Malignancies
•Other active malignancy ≤ 5 years prior to registration. 14.1 Exceptions: Non-melanotic skin cancer or carcinoma-in-situ of the cervix. 14.2 Note: If there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer.
Procedure: therapeutic conventional surgery, Radiation: whole breast irradiation
Breast Cancer, Breast - Female
stage IA breast cancer, stage IB breast cancer, stage II breast cancer, ductal breast carcinoma in situ, lobular breast carcinoma in situ
UT Southwestern; Children’s Health
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Neratinib +/- Fulvestrant in HER2+, ER+ Metastatic Breast Cancer

This research study is studying a drug called Neratinib with and without Fulvestrant as possible treatments for HER2-positive breast cancer . The interventions involved in this study are: - Neratinib and Fulvestrant - Neratinib alone
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Barbara Haley
30339
Female
18 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT03289039
STU 012018-019
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Inclusion Criteria:

• Participants must have histologically or cytologically confirmed inoperable locally advanced or metastatic ER+ breast cancer. To fulfill the requirement for ER+ disease, a breast cancer must express, by immunohistochemistry (IHC), ER in ≥10% of cells, on the most recent biopsy. If ER quantification is not available, a determination of ER+ by IHC will suffice. Central confirmation of ER status is not required.
• Participants must have documented HER2+ disease by overexpression and/or gene amplification on the most recent biopsy, per current ASCO-CAP (American Society of Clinical Oncology
•College of American Pathologists) guidelines. Central confirmation of HER2 status is not required.
• Participants must have received prior therapy with the following agents in any combination, and in setting (i.e., neoadjuvant, adjuvant, metastatic, etc.). These therapies do not need to be the most recent line of therapy.
• Trastuzumab
• Pertuzumab
• Ado-trastuzumab emtansine (T-DM1)
• Participants must agree to undergo a research biopsy of a reasonably accessible metastatic lesion (chest wall, skin, subcutaneous tissue, lymph nodes, skin, breast, bones, lung, and liver metastases). If a reasonably accessible metastatic lesion is not available, the patient may go on study provided that archived tissue is available. However, if a reasonably accessible site is available for biopsy, the patient must agree to biopsy. Any patients not undergoing biopsy must be approved for study enrollment by the Overall Principal Investigator at DFCI. Biopsies may be done with local anesthesia or intravenous conscious sedation, according to institutional guidelines. If a biopsy requires general anesthesia, then it is only allowed if acquisition of tissue is clinically indicated, and excess tissue may be collected for research purposes. Patients without sites available for biopsy must have available tissue [archived formalin-fixed paraffin embedded blocks (FFPB), blocks from which slides can be created, or fresh frozen tissue from original diagnosis or metastatic setting] for correlative studies. Tissue needs to be located and available at the time of registration See Section 9.3 for more details.
• Women ≥ 18 years of age. Men are not eligible.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2 (see Appendix A).
• Participants must have normal organ and marrow function as described below:
• Absolute neutrophil count ≥1,000/uL
• Platelets ≥75,000/uL
• Hemoglobin ≥8g/dL
• Total bilirubin ≤ 1.5 X institutional upper limit of normal (ULN); in case of known Gilbert's syndrome, <2 x ULN is allowed
• AST(SGOT)/ALT(SGPT) ≤3X institutional ULN without liver metastases, or ≤5X institutional ULN with liver metastases
• Creatinine clearance ≥ 50 mL/min
• Left ventricular ejection fraction ≥50%, as determined by RVG (MUGA) or echocardiogram (ECHO) within 60 days prior to initiation of protocol therapy
• Participants may have received any number of prior therapies as long as they have adequate performance status and meet all other eligibility criteria.
• Women of childbearing potential (including premenopausal women and women less than 12 months after menopause) must have a negative β-human chorionic gonadotropin (hCG) urine pregnancy test within 4 weeks of registration.
• The effects of neratinib and fulvestrant on the developing human fetus are unknown. For this reason and because SERD agents are known to be teratogenic, women of child-bearing potential must agree to be abstinent, or to use a highly effective double barrier method of contraception (e.g, a combination of male condom with an intravaginal device such as the cervical cap, diaphragm, or vaginal sponge with spermicide) or a non-hormonal method, while enrolled in the study, until at least 28 days after the last dose of neratinib or 1 year after the last dose of fulvestrant. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately. If a woman is of childbearing potential, she must agree to use adequate contraception prior to the study, for the duration of study participation, and for one year after completion of the study drug.
• Ability to understand and willingness to sign a written informed consent document.
Exclusion Criteria:

• Participants who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to neratinib or fulvestrant.
• Participants who have known hypersensitivity to any component of loperamide or colestipol.
• Participants who have received previous therapy with neratinib.
• Participants who have received anti-cancer therapy (including chemotherapy, biological therapy, investigational agents, hormonal therapy, or other anti-cancer therapy) or radiotherapy within ≤14 days prior to the planned initiation of investigational products, or those who have not recovered to grade ≤1from adverse events due to their most recent therapy (excepting alopecia).
• Participants who have had any major surgery ≤28 days prior to the planned initiation of study therapy, or those who have not recovered from adverse events due to agents/surgery administered more than 4 weeks earlier.
• Participants who are receiving any other investigational agents.
• Participants with known brain metastases that are untreated, symptomatic, or require therapy to control symptoms. Participants with a history of treated central nervous system (CNS) metastases are eligible. Treated brain metastases are defined as those without ongoing requirement for corticosteroids, as ascertained by clinical examination and/or brain imaging (magnetic resonance imaging or CT scan) completed during screening. Any corticosteroid use for brain metastases must have been discontinued without the subsequent appearance of symptoms for ≥ 7 days prior to registration. Treatment for brain metastases may include whole brain radiotherapy, radiosurgery, surgery or a combination as deemed appropriate by the treating physician. Radiation therapy must be completed at least 14 days prior to registration.
• Participant has active, uncontrolled cardiac disease, including cardiomyopathy, congestive heart failure (New York Heart Association functional classification of ≥2), unstable angina, myocardial infarction within 12 months of enrollment, or ventricular arrhythmia.
• Participant has a QTc interval >470 ms or known history of QTc prolongation or Torsade de Pointes.
• Participant has an active infection or unexplained fever >38.5°C (101.3°F).
• Participant has had another malignancy within the past 5 years with the exception of a) adequately treated basal cell carcinoma, squamous cell skin cancer, or thyroid cancer; b) carcinoma in situ of the breast, cervix or vulva; or c) cancer considered cured by surgical resection or unlikely to impact survival during the duration of the study, such as localized transitional cell carcinoma of the bladder, or benign tumors of the adrenal or pancreas.
• Participant has significant chronic gastrointestinal disorder with diarrhea as a major symptom (e.g., Crohn's disease, malabsorption, or Grade ≥2 (NCI CTCAE v.4.0) diarrhea of any etiology at screening).
• Participant has known active infection with hepatitis B or hepatitis C virus. Hepatitis B and C serology testing is not required, unless active infection is suspected.
• Participant is unable or unwilling to swallow tablets.
• Participant has evidence of significant medical illness, abnormal laboratory finding, or psychiatric illness/social situations that would, in the Investigator's judgment, limit compliance with study requirements.
• Pregnant women are excluded from this study because fulvestrant is a SERD agent with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with neratinib and/or fulvestrant, breastfeeding should be discontinued if the mother is treated with neratinib and/or fulvestrant.
Drug: Neratinib, Drug: Fulvestrant
Breast Cancer, Breast - Female
Breast Cancer
UT Southwestern
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DS-8201a in Pre-treated HER2 Breast Cancer That Cannot be Surgically Removed or Has Spread [DESTINY-Breast02]

This study will compare DS 8201a to standard treatment. Participants must have HER2 breast cancer that has been treated before. Their cancer: - cannot be removed by an operation - has spread to other parts of the body
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Barbara Haley
30339
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT03523585
STU-2018-0083
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Inclusion Criteria:

• Is the age of majority in their country
• Has pathologically documented breast cancer that: 1. is unresectable or metastatic 2. has confirmed HER2-positive expression as determined according to American Society of Clinical Oncology
•College of American Pathologists guidelines evaluated at a central laboratory 3. was previously treated with ado-trastuzumab emtansine (T-DM1)
• Has documented radiologic progression (during or after most recent treatment or within 6 months after completing adjuvant therapy)
• Is HER2 positive as confirmed by central laboratory assessment of most recent tumor tissue sample available. If archived tissue is not available, agrees to provide a fresh biopsy.
• Male and female participants of reproductive/childbearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and for at least: 1. 7 months after the last dose of DS-8201a (females); 4.5 months after last dose of DS-8201a (males) 2. 6 months after the last dose of lapatinib/capecitabine for female participants (3 months for male participants) 3. 7 months after the last dose of trastuzumab/capecitabine
• Has adequate hematopoietic, renal and hepatic functions
Exclusion Criteria:

• Has previously participated in an antibody drug conjugate study sponsored by Daiichi Sankyo. Prior treatment in the adjuvant/neo-adjuvant setting would be allowed if progression of disease did not occur within 12 months of end of adjuvant therapy
• Has had prior treatment with capecitabine
• Has uncontrolled or significant cardiovascular disease
• Has a history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening
• Has active central nervous system (CNS) metastases
Drug: Trastuzumab deruxtecan, Drug: Capecitabine, Drug: Lapatinib, Drug: Trastuzumab
Breast Cancer, Breast - Female, Breast - Male
Breast Cancer, Metastatic breast cancer, DS 8201a, DESTINY - Breast 02
UT Southwestern
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Radiation Therapy With or Without Trastuzumab in Treating Women With Ductal Carcinoma In Situ Who Have Undergone Lumpectomy

This randomized phase III trial studies radiation therapy to see how well it works with or without trastuzumab in treating women with ductal carcinoma in situ who have undergone lumpectomy. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known whether radiation therapy is more effective with or without trastuzumab in treating ductal carcinoma in situ.
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Ann Leitch
14231
Female
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT00769379
STU 032012-023
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Inclusion Criteria:

• The patient must have consented to participate and must have signed and dated an appropriate Institutional Review Board (IRB)-approved consent form that conforms to federal and institutional guidelines for the study treatment and for the pre-entry tumor block submission for HER2 testing and B-43 correlative studies
• Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 (0 = fully active, able to carry on all pre-disease performance without restriction; 1 = restricted in physically strenuous activity but ambulatory)
• On histologic examination, the tumor must be ductal carcinoma in situ (DCIS) (patients with mixed DCIS and lobular carcinoma in situ [LCIS] are eligible)
• The DCIS must be HER2-positive as determined by central testing
• Estrogen and/or progesterone receptor status must be determined prior to randomization (patients with DCIS that is hormone receptor positive or negative are eligible)
• All DCIS must have been resected by lumpectomy
• The margins of the resected specimen must be histologically free of DCIS; for patients in whom pathologic examination demonstrates DCIS present at the line of resection, re-excision(s) may be performed to obtain clear margins (patients who require mastectomy are not eligible)
• If axillary staging is performed, nodal staging must be pN0, pN0(i-), pN0(i+) which is defined as isolated tumor cells =< 0.2 mm, regardless of the method of detection, i.e., immunohistochemistry (IHC) or hematoxylin & eosin (H&E), pN0(mol-), or pN0(mol+); note: axillary staging is not required
• The interval between the last surgery for excision of DCIS (lumpectomy or re-excision of lumpectomy margins) and randomization must be no more than 120 days
Exclusion Criteria:

• Invasive (including microinvasion staged as T1mic) breast cancer (patients with DCIS "suspicious" for microinvasion, but not confirmed, are eligible)
• Nodal staging of pN1 (including pN1mi) (note: axillary staging is not required)
• DCIS present in more than one quadrant (multicentric)
• Masses or clusters of calcification that are clinically or mammographically suspicious unless biopsied and proven to be benign (if DCIS is found, the patient is eligible if the DCIS was in the same quadrant of the ipsilateral breast and was resected with clear margins)
• Contralateral breast cancer (including DCIS)
• Whole breast irradiation administered before randomization (partial breast irradiation is prohibited)
• Prior history of breast cancer, including DCIS (patients with a history of LCIS are eligible)
• Prior anthracycline chemotherapy for any malignancy
• Cardiac disease that would preclude the use of the drugs included in the B-43 treatment regimens; this includes but is not confined to:
• Active cardiac disease:
• Angina pectoris that requires the use of anti-anginal medication;
• Ventricular arrhythmias except for benign premature ventricular contractions (PVCs) controlled by medication;
• Conduction abnormality requiring a pacemaker;
• Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication; and
• Clinically significant valvular disease
• History of cardiac disease:
• Myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of left ventricular (LV) function;
• Documented congestive heart failure; or
• Documented cardiomyopathy
• Uncontrolled hypertension, i.e., systolic blood pressure [BP] greater than 180 mm/Hg and/or diastolic BP greater than 100 mm/Hg (patients with hypertension that is well controlled on medication are eligible)
• Other nonmalignant systemic disease that would preclude a patient from receiving trastuzumab or radiation therapy or would prevent prolonged follow-up
• Other malignancies unless the patient is considered to be disease-free for 5 or more years prior to randomization and is deemed by her physician to be at low risk for recurrence; patients with the following cancers are eligible if diagnosed and treated within the past 5 years: carcinoma in situ of the cervix, carcinoma in situ of the colon, melanoma in situ, and basal cell and squamous cell carcinoma of the skin
• Pregnancy or lactation at the time of study entry (note: pregnancy testing according to institutional standards should be performed for women of child-bearing potential)
• Administration of any investigational agent within 30 days before study entry
Other: Laboratory Biomarker Analysis, Biological: Trastuzumab, Radiation: Whole Breast Irradiation
Breast - Female, Breast Ductal Carcinoma In Situ
UT Southwestern; Children’s Health
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Active Breathing Coordinator-based vs VisionRT-based Deep Inspiration Breath-hold for Radiation for Breast Cancer (VisionRT)

Female patients treated with radiation for left-sided breast malignancy will undergo alternate fractions of Active Breathing Coordinator (ABC)-assisted and VisionRT-assisted Deep Inspiration Breath-Hold (DIBH).
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Assal Rahimi
115315
Female
18 Years to 99 Years old
N/A
This study is NOT accepting healthy volunteers
NCT02694029
STU 052015-047
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Inclusion Criteria:

• Women with diagnosis of breast malignancy
• Women whom requires left chest wall post-mastectomy radiation with or without bolus
• Age ≥ 18 years.
• Performance status ECOG • Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately Ability to understand and the willingness to sign a written informed consent.
• Patient must be able to maintain a 30 second breath hold.
• Conventional chest wall radiation delivery dose of 50.4 Gy/ 28 fractions with or without a boost (boost will not be evaluated for endpoints)
Exclusion Criteria:

• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.
Device: Active Breathing Coordinator (ABC), Device: VisionRT
Breast Cancer, Breast - Female
UT Southwestern; Children’s Health
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GammaPod Registry and Quality of Life Nomogram (GCC 1876)

This study is a prospective, single arm study (registry) summarizing patient-level adverse-event and tumor outcomes as well as a number of feasibility and dosimetric characteristics of delivering a single-fraction boost with the GammaPod.
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Assal Rahimi
115315
Female
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT03562273
STU 052018-052
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Inclusion Criteria:

• The patient must sign consent for study participation.
• The patient must be female and have a diagnosis of an invasive or non-invasive breast cancer that was treated surgically by a partial mastectomy.
• The patient must be deemed an appropriate candidate for breast conserving therapy (i.e. not pregnant, never had radiation to the treated breast, breast size would allow adequate cosmesis after volume loss from partial mastectomy).
• Patients with involved lymph nodes are candidates for the study.
• Surgical margins are negative for invasive (no tumor on ink) or non-invasive breast cancer (2 mm negative margin).
• The greatest dimension of the tumor is less than 4cm before surgery.
• Multifocal disease is allowed if it was removed by a single lumpectomy resection and the patient remained a candidate for breast conservation.
• Age 18 years and older.
• Women of childbearing potential (pre-menopausal defined as having a menstrual period within the past 1 year) must have a negative serum pregnancy test or complete a pregnancy waiver form per institutional policy.
• The surgical cavity is clearly visible on CT images. Of note, clips are not required but recommended.
• The patient must weigh less than 150Kg (330lb), which is the limit of the imaging couch.
• The patient must be less than 6'6" in height.
• The patient must feel comfortable in the prone position.
• Diagnosis of prior contralateral breast cancer is allowed.
• Diagnosis of synchronous bilateral cancers is allowed. In this case if bilateral boosts are required, a patient would not have both treatments on the same day.
• Oncoplastic reduction surgery is allowed if the lumpectomy cavity can be clearly visualized.
Exclusion Criteria:

• Patients with proven multi-centric carcinoma (tumors in different quadrants of the breast or tumor separated by at least 4 cm).
• Prior radiation therapy to that breast or that hemi thorax.
• Unable to fit into the immobilization breast cup with an adequate seal.
• Male gender.
• Patient cannot comfortably be set up in the prone position (i.e. physical disability)
• Unable to fit into the breast immobilization device due to breast size or other anatomical reason.
• Mastectomy is the surgery performed.
• Patient has received prior radiotherapy to the involved breast.
• Tumor bed is less than 3 mm from the skin surface.
• Greater than 50% of the target volume is above the upper border of the table.
• Patients with skin involvement, regardless of tumor size.
• Patients with connective tissue disorders specifically systemic lupus erythematosis, scleroderma, or dermatomyositis.
• Patients with psychiatric or addictive disorders that would preclude obtaining informed consent.
• Patients who are pregnant or lactating due to potential exposure of the fetus to RT and unknown effects of RT to lactating females.
• Patients with breast implants/tissue expanders or flap reconstruction.
Radiation: Quality Of Life Sizing Nomogram
Breast Cancer Female, Breast - Female
Breast Nomogram, Breast Cancer Quality of Life, GammaPod Registry
UT Southwestern; Children’s Health
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Understanding and Predicting Breast Cancer Events After Treatment (UPBEAT)

This study is being done to see if patients receiving chemotherapy for breast cancer affects the heart, the ability to exercise and fatigue when compared to patients who do not have cancer.
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Vlad Zaha
163027
Female
18 Years and over
N/A
This study is also accepting healthy volunteers
NCT02791581
STU-2019-1523
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Inclusion Criteria for Women with Stage I
•III Breast Cancer:
• Stage I-III female breast cancer (including inflammatory and newly diagnosed or locally recurrent breast cancer) but not metastatic breast cancer being treated with curative intent
• > 18 years old
• Scheduled to receive chemotherapy and/or estrogen antagonist aromatase inhibitors (anastrozole [Arimidex], letrozole [Femara], exemestane [Aromasin]).
• Able to hold breath for 10 seconds
• ECOG performance status 0 -2
• Able to walk at least 2 blocks without chest pain, dyspnea, shortness of breath or fainting
• Able to exercise on a treadmill or stationary cycle
• Participants in other ongoing clinical trials are eligible for this study Exclusion Criteria for Women with Stage I-III Breast Cancer:
• Those with ferromagnetic cerebral aneurysm clips or other intracranial metal; pacemakers, defibrillators, functioning neurostimulator devices or other implanted non-compatible MRI devices (patients with tissue expanders will not be excluded)
• If previously measured, known LVEF <50%
• Symptomatic claustrophobia
• Unable to provide informed consent
• At the beginning of the study, pregnant women and women who are breast-feeding will not be enrolled.
• Severe pulmonary hypertension
• Within the past 6 months:
• Acute pulmonary embolus
• Deep vein thrombosis
• Within the past month:
• Heart attack
• Unstable or stable angina (cardiac chest pain)
• Left main coronary artery disease
• Symptomatic heart failure
• Uncontrolled hypertension (SBP > 180 mm Hg or DBP > 120 mm Hg)
• Severe valvular heart disease
• Uncontrolled metabolic disease (diabetes with fasting BS >300 mg/dl, thyrotoxicosis, myxedema)
• Aortic aneurism (>45 mm diameter) or aortic dissection
• Uncontrolled slow or fast heart rhythm causing symptoms or hemodynamic compromise
• Hypertrophic obstructive cardiomyopathy
• Patient does not understand English Inclusion Criteria for Women Free of Cancer for Comparison:
• Healthy female without known coronary artery disease > 18 years old
• Able to hold breath 10 seconds
• ECOG performance status = 0 or 1
• Able to walk at least 2 blocks without chest pain, dyspnea, shortness of breath or fainting
• Able to exercise on a treadmill or stationary cycle
• No personal history of cancer other than superficial skin cancers
• Has never received chemotherapy, radiation therapy, immunotherapy, or had breast cancer related surgery
• If previously measured, LVEF ≥ 50% Exclusion Criteria for Women Free of Cancer for Comparison:
• Inflammatory conditions such as lupus or inflammatory bowel disease
• Overt coronary artery disease or heart failure
• Those with ferromagnetic cerebral aneurysm clips or other intracranial metal; pacemakers, defibrillators, functioning neurostimulator devices or other implanted non-compatible MRI devices
• Symptomatic claustrophobia
• Unable to provide informed consent
• At the beginning of the study, pregnant women or women who are breast feeding will not be enrolled.
• Severe pulmonary hypertension
• Within the past 6 months:
• Acute pulmonary embolus
• Deep vein thrombosis
• Within the past month:
• Heart attack
• Unstable or stable angina (cardiac chest pain)
• Left main coronary artery disease
• Symptomatic heart failure
• Uncontrolled hypertension (SBP > 180 mm Hg or DBP > 120 mm Hg)
• Severe valvular heart disease
• Uncontrolled metabolic disease (diabetes with fasting BS >300 mg/dl, thyrotoxicosis, myxedema)
• Aortic aneurism (>45 mm diameter) or aortic dissection
• Uncontrolled slow or fast heart rhythm causing symptoms or hemodynamic compromise
• Hypertrophic obstructive cardiomyopathy
• Patient does not understand English
Diagnostic Test: Cardiac MRI
Breast Cancer, Breast - Female
Breast Cancer, Fatigue, Cardiovascular Events
UT Southwestern; Children’s Health
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Fulvestrant, Palbociclib and Erdafitinib in ER+/HER2-/FGFR-amplified Metastatic Breast Cancer

This is an open-label, multi-institution, phase Ib trial that evaluates the safety and tolerability and preliminary anti-tumor activity of fulvestrant, palbociclib and erdafitinib in patients with ER+/HER2-/FGFR-amplified metastatic breast cancer.
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Barbara Haley
30339
All
18 Years and over
Phase 1
This study is NOT accepting healthy volunteers
NCT03238196
STU 042018-051
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Inclusion Criteria:

• Patients must be able to swallow and retain oral medication
• Patients must be ≥ 18 years of age
• Female patients of no childbearing potential must be post-menopausal. Postmenopausal female subjects should be defined prior to protocol enrollment by any of the following:
• Participants at least 60 years of age; OR
• Participants under 60 years of age and naturally (spontaneous, no alternative pathologic or physiological cause) amenorrhea for at least 12 months; OR
• Medical ovarian failure confirmed by follicle-stimulating hormone (FSH) and estradiol levels in the post menopausal range per local institutional normal range; OR
• Prior bilateral oophorectomy; OR
• Prior radiation castration with amenorrhea for at least 6 months; OR
• Treatment with a luteinizing hormone-releasing hormone (LH-RH) agonist (such as goserelin acetate or leuprolide acetate) is permitted for induction of ovarian suppression as long as it has been initiated at least 28 days prior to study enrollment
• Patients must have ECOG performance status 0
•1
• Patients must have clinical stage IV or inoperable locoregional recurrent invasive mammary carcinoma that is:
• ER+ and/or PgR+ (≥ 1% positive stained cells) by immunohistochemistry (IHC)
• HER2-negative (by IHC or FISH, per ASCO guidelines)
• FGFR1
•4 amplified
• Patients must have evaluable (may have either measurable or non-measurable) disease
• Patients must have available tissue for FGFR determination
• Patients must have had at least one line of therapy in the metastatic setting
• Current use of any of the drugs listed on the Cautionary Concomitant Med list has to be approved by the Study Chair
• Patients must have adequate hematologic, hepatic and renal function. All laboratory tests must be obtained within 2 weeks from study drug initiation. These include:
• ANC ≥ 1,500/mm3
• Platelet count ≥ 100,000/mm3
• HgB ≥ 9.0 g/dL
• Creatinine clearance ≥ 40 mL/min/1.73 m2
• SGOT, SGPT ≤ 2.5 x ULN if no liver metastasis present; SGOT, SGPT ≤ 4 x ULN if liver metastasis present
• Albumin ≥ 2.0 g/dL
• Total serum bilirubin ≤ 1.5 x ULN (≤ 3 x ULN or direct bilirubin ≤ 1.5 x ULN if known Gilbert's syndrome)
• Potassium within institutional normal limits
• Phosphorus ≤ institutional upper limit of normal
Exclusion Criteria:

• Prior use of an FGFR inhibitor
• More than 2 lines of chemotherapy in the metastatic setting. No limit on endocrine therapy lines. Prior exposure to CDK4/6 inhibitor acceptable.
• Radiation therapy ≤ 2 weeks prior to study entry. Patients who have received prior radiotherapy must have recovered from toxicity (≤ grade 1) induced by this treatment (except for alopecia)
• Prior cancer therapy (except for endocrine therapy) must have been discontinued for 1 week prior to initiation of study drugs
• Concurrent anti-cancer therapy other than the ones specified in the protocol is not permitted during study participation. Bisphosphonates or denosumab are allowed
• Major surgery within 4 weeks of enrollment
• Herbal preparations are not allowed throughout the study, and should be discontinued 14 days prior to initiation of study treatment
• Any corneal or retinal abnormality likely to increase the risk of eye toxicity, such as:
• Current corneal pathology such as keratitis, keratoconjunctivitis, keratopathy, corneal abrasion, inflammation or ulceration
• Uncontrolled glaucoma despite standard of care therapy
• Diabetic retinopathy with macular edema
• Known active wet, age-related macular degeneration (AMD)
• Known central serous retinopathy (CSR) or retinal vascular occlusion (RVO)
• Uncontrolled intercurrent illness including, but not limited to:
• Malabsorption syndrome significantly affecting gastrointestinal function
• Ongoing or active infection requiring antibiotics/antivirals
• Impairment of lung function (COPD > grade 2, lung conditions requiring oxygen therapy)
• Symptomatic congestive heart failure
• Unstable angina pectoris, angioplasty, stenting, or myocardial infarction within 6 months
• Clinically significant cardiac arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia that is symptomatic or requires treatment [National Cancer Institute -Common Terminology Criteria for Adverse Events, Version 4.03, grade 3]
• QTcF ≥ 480 msec on screening EKG
• Known history of clinically significant QT/QTc prolongation or Torsades de Pointes(TdP)
• ST depression or elevation of ≥ 1.5 mm in 2 or more leads
• Diarrhea of any cause ≥ CTCAE grade 2 that does not resolve within a few days when adequately treated with anti-diarrhea medications
• Psychiatric illness/social situations that would compromise patient safety or limit compliance with study requirements including maintenance of a compliance/pill diary
• Symptomatic brain metastases (patients with a history of brain metastases must be clinically stable for more than 4 weeks from completion of radiation treatment and be off steroids)
• Known history of chronic liver or chronic renal failure
• Poor wound healing capacity
Drug: Erdafitinib, Drug: Palbociclib, Drug: Fulvestrant
Metastatic Breast Cancer, Breast - Female, Breast - Male
FGFR inhibitor, ER+ metastatic breast cancer, CDK4/6 inhibitor, Endocrine therapy
UT Southwestern
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A Study of Multiple Immune and Disease Treatment Combinations in Participants With ER+HER2- Breast Cancer That Has Spread

The hypothesis of the CA048-001 Phase 1 clinical trial is targeting multiple mechanisms involved in generating and maintaining antitumor immune response will lead to a tolerable and robust anti-tumor response. This study utilizes an innovative clinical trial design to determine the safety, tolerability, pharmacodynamic activity and efficacy of targeting multiple, distinct combination regimens that modulate several immune and non-immune mechanisms by escalating the number of therapies administered.
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Sangeetha Reddy
188773
All
18 Years and over
Phase 1
This study is NOT accepting healthy volunteers
NCT04132817
STU-2020-0606
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For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:

• Histological and cytological confirmation of adenocarcinoma of the breast
• Documented HER2 negative and estrogen receptor (ER) positive status of primary or metastatic tumor tissue using the most recently assessed tumor specimen, according to the local laboratory parameters
• ER negativity is defined as < 1% of tumor cells expressing hormonal receptors via IHC analysis
• At least one measurable lesion, as per Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST v1.1] that can be accurately assessed at baseline and is suitable for repeated assessment by computed tomography (CT) or magnetic resonance imaging (MRI)
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Women and Men must agree to follow specific methods of contraception, if applicable, while participating in the trial
Exclusion Criteria:

• Allergy or hypersensitivity to any study drugs or their excipients
• Any other sound medical, psychiatric and/or social reason as determined by the investigator
• Active, known, or suspected autoimmune disease or immune-related diseases
• History of unstable or deteriorating cardiac disease within the previous 12 months prior to screening
• Prior therapy with anti-programmed death 1 (PD-1), anti-programmed death-ligand 1 (PD-L1) or anti-Cytotoxic T Lymphocyte Antigen 4 (CTLA-4) class antibody
• Any major surgery within 4 weeks of the first dose of study treatment Other protocol-defined inclusion/exclusion criteria apply
Biological: Nivolumab, Biological: Ipilimumab, Drug: Nab-paclitaxel
Breast Cancer, Breast - Female, Breast - Male
UT Southwestern; Children’s Health
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DS-8201a Versus T-DM1 for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane [DESTINY-Breast03]

This study is designed to compare the anti-tumor activity as well as the safety and efficacy of DS-8201a versus T-DM1 in HER2-positive, unresectable and/or metastatic breast cancer subjects previously treated with trastuzumab and taxane.
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Barbara Haley
30339
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT03529110
STU-2018-0164
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Inclusion Criteria:

• Is the age of majority in their country
• Has pathologically documented breast cancer that: 1. is unresectable or metastatic 2. has confirmed HER2-positive expression as determined according to American Society of Clinical Oncology
•College of American Pathologists guidelines evaluated at a central laboratory 3. was previously treated with trastuzumab and taxane in the advanced/metastatic setting or progressed within 6 months after neoadjuvant or adjuvant treatment involving a regimen including trastuzumab and taxane
• Has documented radiologic progression (during or after most recent treatment or within 6 months after completing adjuvant therapy)
• Is HER2 positive as confirmed by central laboratory assessment of most recent tumor tissue sample available. If archived tissue is not available, agrees to provide a fresh biopsy.
• If of reproductive/childbearing potential, agrees to use a highly effective form of contraception or avoid intercourse during and upon completion of the study for 7 months after the last dose of DS-8201a (females); 4.5 months after last dose of DS-8201a (males) or 7 months after the last dose of T-DM1
• Has adequate renal and hepatic function
Exclusion Criteria:

• Has previously been treated with an anti-HER2 antibody drug conjugate (ADC) in the metastatic setting. Prior treatment in the adjuvant/neo-adjuvant setting would be allowed if progression of disease did not occur within 12 months of end of adjuvant therapy
• Has uncontrolled or significant cardiovascular disease
• Has a history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening
• Has spinal cord compression or clinically active central nervous system (CNS) metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms. 1. Participants with clinically inactive brain metastases may be included in the study. 2. Participants with treated brain metastases that are no longer symptomatic and who require no treatment with corticosteroids or anticonvulsants may be included in the study if they have recovered from the acute toxic effect of radiotherapy. A minimum of 2 weeks must have elapsed between the end of whole brain radiotherapy and study enrollment.
Drug: Trastuzumab deruxtecan (DS-8201a), Drug: Ado-trastuzumab emtansine (T-DM1)
Breast Cancer, Breast - Female, Breast - Male
Breast Cancer, Metastatic breast cancer, DS-8201a, DESTINY - Breast 03
UT Southwestern
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Early Surgery or Standard Palliative Therapy in Treating Patients With Stage IV Breast Cancer

RATIONALE: Early surgery may have fewer side effects and improve recovery. Palliative surgery or radiation therapy may help patients with advanced breast cancer live more comfortably. It is not yet known whether early surgery is more effective than palliative therapy for advanced breast cancer. PURPOSE: This randomized phase III trial is studying early surgery to see how well it works compared to standard palliative therapy in treating patients with stage IV breast cancer.
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Assal Rahimi
115315
All
18 Years to 120 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT01242800
STU 032011-073
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DISEASE CHARACTERISTICS:
• Diagnosis of intact primary (not recurrent) invasive carcinoma of the breast
• Stage IV disease
• Confirmation of the primary tumor should be by needle biopsy (preferred)
• Incisional surgical biopsy allowed as long as there is residual palpable or tumor image in the breast
• Patients must be judged to be candidates for complete resection with free margins followed by radiation therapy (if radiation therapy is indicated)
• For women not undergoing axillary dissection, sentinel node biopsy should document an axillary nodal burden of 1-2 involved lymph nodes (i.e., ACOSOG Z-11 criteria may be applied)
• Prior non-invasive (DCIS) cancer allowed provided there has been no recurrence
• Prior ipsilateral invasive cancer allowed if more than 5 years previous
• No synchronous contralateral breast cancer
• Patients should have at least one organ system involved with distant metastatic disease
• If patient has only one metastatic lesion/focus, this must be proven by biopsy and the pathology report confirming the diagnosis of primary breast cancer, as well as the metastatic site, must be available
• Must have available radiologic reports documenting disease status within the past 6 weeks prior to initiating systemic therapy
• CNS metastases allowed provided projected survival > 6 months
• Patients must have completed at least 16 weeks of optimal systemic therapy (appropriate to the tumor biological profile and the patient's age and menopausal status)
• If systemic therapy is discontinued for toxicity, but there is no distant progression and at least 12 weeks of therapy have been delivered, then the patient remains eligible
• Radiation therapy (if indicated) must begin within 12 weeks of final therapeutic surgical procedure (including re-excision for free margins and completion of axillary dissection)
• Patients may register at any time from the time of diagnosis of stage IV breast cancer (if eligibility criteria met) to the time when a maximum of 30 weeks of induction systemic therapy has been completed
• Patients must be randomized within 16-32 weeks after the start of systemic therapy
• Patients must not have experienced disease progression since the start of systemic therapy, as evidenced by radiographic documentation of disease status before treatment and within 4 weeks +/- 2 weeks prior to randomization, including:
• No new sites of disease
• No enlargement of existing sites by 20% or more in longest diameter
• No symptomatic deterioration
• Patients who require radiotherapy to bone metastases during induction systemic therapy are eligible
• Local disease at the primary site must be asymptomatic
• Hormone receptor status known PATIENT CHARACTERISTICS:
• See Disease Characteristics
• Menopausal status not specified
• Patients must have adequate organ function to undergo local therapy 4 weeks +/- 2 weeks prior to randomization per investigator discretion and institutional guidelines
• More than 5 years since other primary cancers that were curatively treated
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use an accepted and effective contraception method PRIOR CONCURRENT THERAPY:
• See Disease Characteristics
Procedure: palliative surgery, Procedure: therapeutic conventional surgery, Radiation: palliative radiation therapy, Radiation: radiation therapy
Breast Cancer, Breast - Female
male breast cancer, stage IV breast cancer
UT Southwestern; Children’s Health
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Phase I/II Study of U3-1402 in Subjects With Human Epidermal Growth Factor Receptor 3 (HER3) Positive Metastatic Breast Cancer

This is an open-label, three-part, multiple-dose study to evaluate safety, tolerability, and efficacy of U3-1402 in patients with HER3-positive metastatic breast cancer. HER3 is a unique member of the human epidermal growth factor receptor, which defines a certain type of cancer. The number of patients and treatment cycles are not fixed in this study. Subjects who continue to derive clinical benefit from the study treatment in the absence of withdrawal of consent, progressive disease (PD), unacceptable toxicity, or death may continue the study treatment until the end of the trial.
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Barbara Haley
30339
All
18 Years and over
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT02980341
STU-2018-0080
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Inclusion Criteria:
1. Is 18 Years and older in the United States or 20 Years and older in Japan 2. Has a pathologically documented advanced/unresectable or metastatic breast cancer 3. Documented HER3-positive disease measured by immunohistochemistry (IHC) 4. Has disease that is refractory to or intolerable with standard treatment, or for which standard treatment no longer is available 5. Has an Eastern Cooperative Oncology Group Performance Status 0-1 6. Has Left Ventricular Ejection Fraction ≥ 50% 7. Has measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 Additional Inclusion Criteria for Dose Finding Part and Dose Expansion Part: 8. Has received 2-6 prior chemotherapy regimens for breast cancer, at least 2 of which were administered for treatment of advanced/unresectable or metastatic disease. At least 1 prior chemotherapeutic regimen must have included a taxane, administered in the neoadjuvant, adjuvant, or advanced setting. (With exception of Dose Expansion Part TNBC cohort. See additional inclusion criteria for Dose Expansion Part TNBC cohort.) Additional Inclusion Criteria for Dose Expansion Part Only: 9. Is able to submit a fresh tumor biopsy sample prior to starting study treatment if not already submitted for HER3 expression 10. Has documented hormone (estrogen and/or progesterone) receptor (HR)-positive and HER2 negative expression according to American Society of Clinical Oncology
•College of American Pathologists (ASCO-CAP) guidelines. (With exception of Dose Expansion Part TNBC cohort. See additional inclusion criteria for Dose Expansion Part TNBC cohort.) Additional Inclusion Criteria for Dose Expansion Part TNBC cohort Only: 11. Has documented hormone (estrogen and progesterone) receptor (HR)-negative and HER2 negative expression according to American Society of Clinical Oncology
•College of American Pathologists (ASCO-CAP) guidelines 12. Has progressed after receiving 1 to 2 prior chemotherapy regimens for advanced/unresectable or metastatic breast cancer.
Exclusion Criteria:
1. Prior treatment with a HER3 antibody 2. Prior treatment with an antibody-drug conjugate (ADC) which consists of an exatecan derivative that is a topoisomerase I inhibitor (eg, DS-8201) 3. Has a medical history of symptomatic congestive heart failure (New York Heart Association classes II-IV) or serious cardiac arrhythmia requiring treatment 4. Has a medical history of myocardial infarction or unstable angina 5. Has a corrected QT prolongation to > 450 millisecond (ms) in males and > 470 ms in females 6. Has a medical history of clinically significant lung diseases (eg, interstitial pneumonia, pneumonitis, pulmonary fibrosis, and radiation pneumonitis) or who are suspected to have these diseases by imaging at screening period 7. Has clinically significant corneal disease Additional Exclusion Criteria for Dose Expansion Part: 8. Prior treatment with an govitecan derivative (eg, IMMU-132).
Drug: U3-1402
Metastatic Breast Cancer, Breast - Female, Breast - Male
Oncology, HER3, Antibody drug conjugate, Developmental Phase I/II
UT Southwestern
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Effect of Cardiotoxic Anticancer Chemotherapy on the Metabolism of [1-13C]Pyruvate in Cardiac Mitochondria (HPCardiotox)

The anthracycline doxorubicin, first introduced in the 1960's, continues to be an effectively utilized antineoplastic drug. Even at relatively low cumulative doses there is risk of cardiotoxicity. However, the incidence of subclinical cardiotoxicity is not known, carrying a potential risk for late effects in cancer survivors. Doxorubicin has systemic toxicity that may contribute to cardiac metabolic stress, but the main cardiotoxic mechanism involves cardiac mitochondria. The goal of this study is to detect early changes in the mitochondrial metabolism in situ as a marker for subclinical doxorubicin induced cardiotoxicity.
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Vlad Zaha
163027
All
18 Years and over
Early Phase 1
This study is NOT accepting healthy volunteers
NCT03685175
STU 072016-058
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Inclusion Criteria:

• Breast cancer tissue diagnosis
• Plan for treatment with doxorubicin
• Neoadjuvant patients
• Age ≥ 18 years
• Ability to understand and the willingness to sign a written informed consent
• While all races and ethnicities will be included, subjects must be able to read and speak the English language. Once the protocol is established, Spanish-speaking participants will be included.
• Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Exclusion Criteria:

• Subjects who have alternative chemotherapy or left sided radiotherapy
• Subjects who are receiving any other investigational agents
• Subjects with known macro metastases should be excluded from this clinical trial because of their poor prognosis.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Pregnant
• Diabetic Contraindication to MRI
•claustrophobia, metal in body, facial tattoos / major tattoos, tissue expanders
Drug: Formal study using hyperpolarized 13C-pyruvate injection, Drug: Feasible study using hyperpolarized 13C-pyruvate injection
Breast Neoplasms
Magnetic Resonance Imaging, Doxorubicin
UT Southwestern; Children’s Health
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Phase II Multi-center Trial Evaluating 5 Fraction Stereotactic Partial Breast Irradiation Using Gammapod

Stereotactic radiation has been implemented more than 3 decades ago, initially to radiate benign and later malignant tumors within the brain. Doses up to 24 Gy in one session have been used. Hundreds of thousands of patients have been treated worldwide with very good outcomes . Over the last decade, the stereotactic radiation techniques have been implemented to treat extra-cranial tumors. The challenges of extra cranial tumors were in part target motion during the radiation session, but also accurate re positioning of the patient and of the target volume at time of radiation treatment. Specific immobilization devices are now available to improve accuracy of target localization. Stereotactic radiation therapy is widely available, non-invasive for the patient and less operator dependent as the planning process (from target volume to dose calculation) can be done and verified by different operators through a quality assessment procedure. Stereotactic radiation is a complex type of 3D CRT that is a very attractive technique making the 3D CRT more conformal and more accurate delivery of the prescription dose within the target volume with a very good sparing of surrounding normal tissue. The principles of stereotactic radiation are the following: precise image definition of target volume and OARs, very conformal radiation treatment.
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Assal Rahimi
115315
Female
18 Years to 99 Years old
N/A
This study is NOT accepting healthy volunteers
NCT03581136
STU 042018-083
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Inclusion Criteria:
Women who satisfy all of the following conditions will be eligible for this study. 1 DCIS or invasive ductal, medullary, papillary, mucinous (colloid), lobular,or tubular histologies 2. Age ≥ 18 years. 3. ECOG Performance status 0-2 4. Women of child-bearing potential must agree to use adequate contraception (barrier method of birth control- condom or diaphragm and spermicidal foam; intrauterine device, prescription birth control pills, or abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. 5. A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
• Has not undergone a hysterectomy or bilateral oophorectomy; or
• Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months). 6. Appropriate staging studies identifying as AJCC stage Tis, or T1-T2, N0 (N0i+). The tumor size must be 3 cm or less. 7. Surgical treatment of the breast with lumpectomy with histologically confirmed margins free of tumor (no ink on margin) for invasive disease, and at least 2mm for Ductal Carcinoma In Situ.. (Re-excision of margins is permitted). 8. Gross disease within the breast must be unifocal. (Patients with microscopic multifocality are eligible as long as the total extent of tumor, gross and microscopic, occupies a volume with greatest dimension extent of 3 cm or less (regarding the largest diameter of volume occupying space). 9. Patients with invasive disease are required to have axillary staging including: sentinel node biopsy or axillary dissection. If patients are over age 65, axillary staging is at the discretion of the physician. Patients with DCIS are not required to have axillary staging. 10. Lymphovascular invasion is allowed if limited or focal. 11. Ability to understand and the willingness to sign a written informed consent
Exclusion Criteria:
1. Men are not eligible for this study. 2. T2(>3.0 cm), T3, N1, stage III, or stage IV breast cancer 3. Evidence by physical examination or mammography of other suspicious masses, densities, or microcalcifications in either breast, unless biopsied and found to be benign. 4. Patients with non-epithelial breast malignancies such as sarcoma or lymphoma are excluded. 5. Paget's disease of the nipple. 6. Previous thoracic or breast radiation on ipsilateral side. Contralateral breast radiation is not excluded. 7. Treatment plan that includes ipsilateral whole breast or ipsilateral regional nodal irradiation. 8. Any prior treatment with radiation, or chemotherapy (in the neoadjuvant setting) for currently diagnosed breast cancer prior to GammaPod treatment- adjuvant chemotherapy is acceptable. 9. Patients with active collagen vascular disease, specifically dermatomyositis with a CPK level above normal or active skin rash, systemic lupus erythematosis, or scleroderma, or no other exclusions. 10. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, immunosuppressed patients or psychiatric illness/social situations that would limit compliance with study requirements. 11. Subjects must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants. 12. If the lumpectomy cavity is completely outside of the vacuum assisted breast cup, then patient should not be treated on the GammaPod secondary to concerns of reproducibility. 13. Transplant patients or any patients on immunosuppressive therapy. 14. Breast size that is too large for the breast cup immobilization device.
Device: Dose Fractionation
Breast Cancer
UT Southwestern; Children’s Health
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Surgery to Remove the Sentinel Lymph Node and Axillary Lymph Nodes After Chemotherapy in Treating Women With Stage II, Stage IIIA, or Stage IIIB Breast Cancer

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase II trial is studying surgery to remove the sentinel lymph node and axillary lymph nodes after chemotherapy in treating women with stage II, stage IIIA, or stage IIIB breast cancer.
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Ann Leitch
14231
Female
18 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT00881361
STU 012011-030
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Eligibility Criteria: 1. ≥ 18 years old 2. ECOG/Zubrod Performance Status 0-1 3. Female. Note: Men are excluded from this study because the number of men with breast cancer is insufficient to provide a statistical basis for assessment of effects in this subpopulation of people with breast cancer. 4. Histologic diagnosis of invasive breast cancer, clinical stage T0-4 N1-2 M0 (excluding inflammatory breast cancer). 5. FNA biopsy or core needle biopsy of an axillary node documenting nodal disease at time of diagnosis and prior to preoperative chemotherapy. 6. Preoperative chemotherapy must be completed or planned for patient. NOTE: Patients enrolling on studies involving preoperative chemotherapy (through cooperative groups or institutional studies) may be eligible for this study, provided sentinel node surgery prior to preoperative chemotherapy was not required in the other studies. 7. No prior ipsilateral axillary surgery, such as excisional biopsy of lymph node(s) or treatment of hidradenitis. 8. No prior SLN surgery/excisional lymph node biopsy for pathological confirmation of axillary status.
Drug: systemic chemotherapy, Procedure: axillary lymph node dissection, Procedure: neoadjuvant therapy, Procedure: sentinel lymph node biopsy, Procedure: therapeutic conventional surgery, Procedure: ultrasound imaging
Breast Cancer, Breast - Female
stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer
Children’s Health
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Dose Escalation Study of Single Fraction Early Stage Breast Cancer

The purpose of this phase I trial is to evaluate dose-limiting toxicity while dose escalating single-fraction preoperative S-PBI to a presumed radioablative dose over 3 cohorts, starting with 30Gy in 1 fraction and advancing to 34Gy and 38Gy in 1 fraction.
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Assal Rahimi
115315
Female
18 Years and over
Phase 1
This study is NOT accepting healthy volunteers
NCT04040569
STU-2019-1183
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Inclusion Criteria:
1. Invasive epithelial (ductal, medullary, lobular, papillary, mucinous (colloid), or tubular) histologies of the breast 3 cm or less(T1-T2cN0) in women who have not undergone surgery or neoadjuvant endocrine or chemotherapy for current breast cancer diagnosis 2. Tumor must not involve the overlying skin based on imaging evaluation and/or clinical exam 3. Age >/= 18 years old and female 4. Greatest Tumor dimension is 3cm or less based on US. MRI measurements can be included only if performed BEFORE the biopsy 5. Tumor must be unifocal 6. The tumor must be visible on CT scan and/or preferably marked with clip(s) in tumor 7. Patients must undergo an MRI for work up to aid in tumor delineation and to rule out additional foci of disease. If additional foci of disease are present, they need to have a negative biopsy to proceed with treatment.If patient cannot have MRI, contrast enhanced digital mammography (CEDM) is allowed in place of MRI. 8. Clinically and radiographically node negative on ultrasound of the axilla or MRI 9. Estrogen receptor positive or Progesterone receptor positive and Her2neu negative 10. Ability to understand and the willingness to sign a written informed consent. 11. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to the start of study and for the duration of radiation therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
• Has not undergone a hysterectomy or bilateral oophorectomy; or
• Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months
Exclusion Criteria:
1. Multi-centric disease 2. Prior RT to the involved breast 3. Tumor size >3cm 4. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements 5. Patients who are pregnant or lactating due to the potential exposure to the fetus to radiation therapy and unknown effects of radiation therapy to lactating females 6. Patients unable to have an MRI or contrast enhanced digital mammography (CEDM) 7. Prior ipsilateral breast cancer 8. Tumor less than 5mm from the skin surface on clinical exam and/or radiographic imaging 9. Patients with active Lupus or scleroderma
Radiation: Radiomics on MRI
Breast Cancer, Breast - Female
UT Southwestern
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Single Cell Immune and Non-immune Correlates of Response to Neoadjuvant Abemaciclib

The purpose of this study is to better understand how the immune system plays a role in fighting breast cancer and specifically research if the immune system response against breast cancer can be improved with endocrine therapy and cyclin dependent kinase inhibitor therapy in patients with hormone receptor positive breast cancer. This will be studied by collecting tumor tissue and blood samples before and after 2 weeks of study treatment with commonly used endocrine therapy and cyclin dependent kinase inhibitor therapy.
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Sangeetha Reddy
188773
Female
18 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT04614194
STU-2020-1043
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INCLUSION CRITERIA:
• Clinical stage operable stage I, II, or III invasive mammary carcinoma, which is estrogen receptor or progesterone receptor positive by immunohistochemistry and HER2 negative by Herceptest (0 or 1+) or not amplified by in situ hybridization as per routine clinical testing.
• Have post-menopausal status, as defined by any of the following: Subjects at least 55 years of age OR Subjects under 55 years of age and amenorrheic for at least 12 months OR follicule stimulating hormone (FSH) values ≥ 40 IU/L and estradiol levels ≤ 40 pg/mL (140 pmol/L) or in postmenopausal ranges per local or institutional reference ranges.
• Breast tumor ≥1cm in diameter by either physical exam or ultrasound and suitable for pre and post-treatment tissue sampling.
• Meet either of 2 following criteria, for which neoadjuvant endocrine therapy for 2 weeks is deemed suitable: 1) disease that is planned for surgery as initial therapy, in which 2 weeks of neoadjuvant endocrine therapy is deemed suitable, 2) Disease for which neoadjuvant systemic therapy (either chemotherapy or endocrine therapy) may be planned, in which 2 weeks of neoadjuvant endocrine therapy prior to start of systemic therapy is deemed suitable.
• At least 18 years of age
• Performance status ECOG ≤ 2
• Have adequate organ function (ANC ≥1,500/mcL, Platelets ≥100,000/mcL, Hemoglobin ≥8 g/dL, Total bilirubin ≤1.5 × upper limit of normal, ALT and AST ≤3 × upper limit of normal, Creatinine clearance >30 mL/minute
• The patient is able to swallow oral medications
• Patients with a prior history of contralateral breast cancer are eligible if they have no evidence of recurrence of their initial primary breast cancer.
• Women may have been taking tamoxifen or raloxifene as a preventive agent prior to study entry but must have discontinued the drug for at least 28 days prior to study enrollment.
• Subjects have ended hormone replacement therapy at least 7 days prior to receiving the first dose of randomized therapy.
• Ability to understand and the willingness to sign a written informed consent. EXCLUSION CRITERIA:
• Active metastatic breast cancer, inflammatory breast cancer, or locally recurrent breast cancer.
• The patient has serious and/or uncontrolled preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study (for example, interstitial lung disease, severe dyspnea at rest or requiring oxygen therapy, severe renal impairment [e.g. estimated creatinine clearance <30ml/min], history of major surgical resection involving the stomach or small bowel, or a preexisting chronic condition resulting in baseline grade 2 or higher diarrhea).
• Females who are pregnant, lactating, or premenopausal.
• Severe uncontrolled malabsorption condition or disease (i.e. grade 2 or higher diarrhea, severe malnutrition, short gut syndrome).
• Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
• Chemotherapy, radiotherapy, or any other cancer therapy for current diagnosis of breast cancer.
• Subjects may not have received or be receiving any other investigational agents for the treatment of the cancer under study.
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to abemaciclib or other agents used in study.
• Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements.
Drug: Letrozole, Drug: Abemaciclib
Breast Cancer, Breast - Female
UT Southwestern
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A Study of TAS-120 in Patients With Metastatic Breast Cancer

The purpose of this open-label, nonrandomized, Phase 2 study is to evaluate the efficacy and safety of TAS-120 and TAS-120 + fulvestrant in patients with locally advanced/metastatic breast cancer harboring FGFR gene amplifications.
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Nisha Unni
148963
All
18 Years and over
Phase 2
This study is NOT accepting healthy volunteers
NCT04024436
STU-2019-1362
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Inclusion Criteria:
1. Histologically or cytologically confirmed recurrent locally advanced or metastatic breast cancer not amenable to treatment with curative intent, meeting all of the criteria for 1 of the following cohorts: A. Cohort 1 i. HR+ HER2- breast cancer harboring an FGFR2 gene amplification. HR+ HER2- breast cancer is defined per the local pathology report as estrogen receptor (ER) >1% and/or progesterone receptor (PR) >1%, HER2-negative per American Society of Clinical Oncology (ASCO) and the College of American Pathologists (CAP) guidelines, 2018. ii. Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 iii. Has received 1-3 prior endocrine-containing therapies and up to 2 prior chemotherapy regimens for advanced/metastatic disease iv. Has received prior treatment with a CDK4/6 inhibitor or is ineligible for such i. treatment (per Investigator decision) ii. Has experienced disease progression/recurrence within 1 month following the completion of any endocrine therapy for advanced/metastatic breast cancer B. Cohort 2 i. TNBC harboring an FGFR2 gene amplification. TNBC is defined as negative for ER, PR and HER2. Negative for ER and PR includes the following: local pathology report classifies them as negative, Allred Score of 2 or below or <1% staining. HER2-negative per ASCO / CAP guidelines, 2018. ii. Measurable disease per RECIST 1.1 iii. Has received at least 1 prior chemotherapy or chemotherapy/immunotherapy iv. (PD-L1/PD-1 inhibitors) regimen for advanced/metastatic disease Has experienced disease progression/recurrence during or after the most recent prior chemotherapy for advanced/metastatic breast cancer C. Cohort 3 i. TNBC or HR+ HER2- breast cancer (defined as above) harboring an FGFR2 gene amplification ii. Non measurable, evaluable disease per RECIST 1.1. Patients with bone-only disease must have lytic or mixed lytic-blastic lesions iii. Other criteria for either HR+ HER2- breast cancer or TNBC should be met as described for Cohort 1 and 2, respectively D. Cohort 4 i. HR+ HER2- breast cancer (defined as above) harboring an FGFR1 high-level gene amplification ii. Measurable disease per RECIST 1.1 iii. Has received 1-2 prior endocrine-containing therapies and no more than 1 prior chemotherapy regimen for advanced/metastatic disease. Prior treatment with fulvestrant is not permitted. iv. Has received prior treatment with a CDK4/6 inhibitor or is ineligible for such i. treatment (per Investigator decision) ii. Pre/peri-menopausal patients must be on goserelin. Patients must have commenced treatment with goserelin or an alternative GnRH agonist at least 4 weeks prior to the first dose of fulvestrant. If patients have received an alternative GnRH agonist prior to study entry, they must switch to goserelin for the duration of the trial. Postmenopausal is defined as at least one of the following criteria: age ≥60 years; age <60 years and cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and serum estradiol and follicle-stimulating hormone level within the laboratory's reference range for postmenopausal females; or documented bilateral oophorectomy. iii. Has experienced disease progression/recurrence within 1 month following the completion of any endocrine therapy for advanced/metastatic breast cancer. 2. Archival or (preferably) fresh tumor tissue must be available for central laboratory confirmation of FGFR amplification. 3. The patient has adequate organ function as defined by the following criteria: 1. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0 × the upper limit of normal (ULN); if liver function abnormalities are due to underlying liver metastases, AST and ALT ≤5 × ULN 2. Total bilirubin ≤1.5 × ULN or ≤3 × ULN in case of Gilbert's syndrome 3. Absolute neutrophil count (ANC) ≥1.0 × 109/L without hematopoietic growth factor support 4. Platelet count ≥75 × 109/L without transfusion support (that is, excluding measurements obtained within 3 days after transfusion of platelets) 5. Hemoglobin ≥9.0 g/dL without transfusion support (that is, excluding measurements within 7 days after transfusion of packed red blood cells or whole blood) 6. Serum phosphorus ≤ ULN 7. Creatinine clearance (calculated or measured value): ≥40 mL/min
Exclusion Criteria:
A patient must not meet any of the following exclusion criteria to be eligible for this study: 1. History and/or current evidence of any of the following disorders: 1. Non-tumor related alteration of the calcium-phosphorus homeostasis that is considered clinically significant in the opinion of the Investigator 2. Ectopic mineralization/calcification, including but not limited to soft tissue, kidneys, intestine, or myocardia and lung, considered clinically significant in the opinion of the Investigator 3. Retinal or corneal disorder confirmed by retinal/corneal examination and considered clinically significant in the opinion of the Investigator. 2. Corrected QT interval using Fridericia's formula (QTcF) >470 msec. Patients with an atrioventricular pacemaker or other condition (for example, right bundle branch block) that renders the QT measurement invalid are an exception and the criterion does not apply. 3. Treatment with any of the following within the specified time frame prior to the first dose of TAS-120: 1. Major surgery within 4 weeks (the surgical incision should be fully healed) 2. Radiotherapy for extended field within 4 weeks or limited field radiotherapy within 2 weeks 3. Any prior systemic therapy regardless of the stop date, but the patient must have recovered to eligibility levels from prior toxicity 4. Any investigational agent received within 30 days or 5 half-lives (whichever is shorter) 4. Prior treatment with an FGFR inhibitor 5. Cohort 4 only: Prior treatment with fulvestrant, or known hypersensitivity to fulvestrant. 6. A serious illness or medical condition(s) including but not limited to the following: 1. Known acute systemic infection 2. Myocardial infarction, severe/unstable angina, or symptomatic congestive heart failure within the previous 6 months 3. History or current evidence of serious uncontrolled ventricular arrhythmia 4. Chronic diarrhea diseases considered to be clinically significant in the opinion of the Investigator 5. Congenital long QT syndrome, or any known history of torsade de pointes, or family history of unexplained sudden death 6. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or TAS-120 administration, or may interfere with the interpretation of study results, and in the judgment of the Investigator would make the patient inappropriate for entry into this study 7. Brain metastases that are untreated or clinically or radiologically unstable (that is, have been stable for <1 month) 8. History of another primary malignancy that is currently clinically significant or currently requires active intervention 9. Pregnant or lactating female
Drug: TAS-120, Drug: Fulvestrant
Metastatic Breast Cancer, FGFR2 Amplification, Breast - Female, Breast - Male
Futibatinib, Metastatic Breast Cancer, FGFR, TAS-120
UT Southwestern; Children’s Health
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Investigation of Diagnostic Improvement Gained Through Optimization of MR Methods for Breast Cancer Detection (BCD)

In a single MRI exam on a research scanner, each lesion will be categorized using the BI-RADS MRI score, which utilizes the DCE data alone, and then again using a modified BI-RADS score, which utilizes both DWI and DCE data. The sensitivity and specificity of each approach will be determined using pathology as the gold standard.
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Elena Vinogradov
131699
Female
18 Years and over
N/A
This study is NOT accepting healthy volunteers
NCT02411760
STU 052014-042
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Inclusion Criteria:
Women with Breast Imaging-Reporting and Data System (BI-RADS) 4 or 5 Age ≥ 18 years Ability to understand and the willingness to sign a written informed consent.
Exclusion Criteria:
Subjects who have had a needle biopsy of the suspicious area within the last 6 weeks Subjects who have contraindication to contrast enhanced MRI examination. Contraindications to MRI examinations include: Medically unstable
• Heart failure
• Unstable angina
• Child bearing
• Lactating Any contraindication per MRI Screening Form (Appendix A attached).
• Implants contraindicated at 3T, pacemakers
• Poorly controlled diabetes
• Body weight greater than 300 pounds
• Claustrophobic Since each patient is receiving a gadolinium based contrast agent intravenously:
• eGFR < 60 mL/min/1.73m2
• Sickle cell disease
• Hemolytic anemia Subjects must not be pregnant or nursing due to the potential for gadolinium contrast agents to harm fetuses or nursing infants.
Procedure: 3 Tesla Magnetic Resonance Imaging
Breast Neoplasms, Breast - Female
MRI
UT Southwestern; Children’s Health
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Breast Cancer WEight Loss Study (BWEL Study)

This randomized phase III trial studies whether weight loss in overweight and obese women may prevent breast cancer from coming back (recurrence). Previous studies have found that women who are overweight or obese when their breast cancer is found (diagnosed) have a greater risk of their breast cancer recurring, as compared to women who were thinner when their cancer was diagnosed. This study aims to test whether overweight or obese women who take part in a weight loss program after being diagnosed with breast cancer have a lower rate of cancer recurrence as compared to women who do not take part in the weight loss program. This study will help to show whether weight loss programs should be a part of breast cancer treatment.
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canceranswerline@utsouthwestern.edu
Ann Leitch
14231
Female
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT02750826
STU 082016-030
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1. Documentation of Disease: 1.1 Subjects must have histologically confirmed invasive breast cancer and registration must occur within 14 months after the first histologic diagnosis of invasive breast cancer.
• A core biopsy interpreted as invasive cancer meets this criterion; if no core biopsy is performed, the date of first histologic diagnosis will be the date of first surgical procedure that identifies invasive cancer (biopsy, lumpectomy or mastectomy).
• Neoadjuvant subjects should have no evidence of clinical T4 disease prior to chemotherapy and surgery; eligibility for neoadjuvant patients can be defined by either clinical stage prior to therapy or pathologic stage at surgery; if patient is eligible based on either, they are eligible for the study.
• Bilateral breast carcinoma is allowed provided diagnoses are synchronous
•that is, within 3 months of one another
•and at least one of the two breast carcinomas meet the eligibility criteria and neither Her-2 positive or inflammatory.
• No evidence of metastatic disease 1.2 Her-2 negative, defined as:
• In-situ hybridization (ISH) ratio of < 2.0 (if performed)
• Immunohistochemistry (IHC) staining of 0-2+ (if performed)
• Deemed to not be a candidate for Her-2 directed therapy. 1.3 Eligible tumor-node-metastasis (TNM) Stages include:
• Estrogen receptor (ER) and Progesterone receptor (PR) negative (defined as <1% staining for ER and PR by IHC): T2 or T3 N0, T0-3N1-3. Note: Patients with T1, N1mi disease are NOT eligible.
• ER and/or PR positive (defined as ≥ 1% staining for ER and/or PR on IHC): T0-3N1-3 or T3N0. Note: Patients with T0N0, T1N0, T2N0 or T1N1mi and T2N1mi disease are NOT eligible.
• The eligibility of neo-adjuvant subjects can be assessed on the basis of clinical (c)TNM or pathologic (yp)TNM. The same eligible TNM combinations apply; patients may be eligible if they meet eligibility requirements at either time point, as long as they do not have T4 disease prior to therapy. 1.4 No history of invasive breast cancer in 5 years prior to study registration other than the current diagnosis (prior ductal breast carcinoma in situ [DCIS] at any time is acceptable). 1.5 Patients must have had a bilateral mammogram within 12 months prior to registration, unless the initial surgery was a total mastectomy, in which case only a mammogram of the remaining breast is required. (Subjects with bilateral total mastectomies do not require imaging). 1.6 Investigations, including chest X-ray or computed tomography (CT) chest, bone scan (with radiographs of suspicious areas) and abdominal ultrasound or liver scan or CT abdomen have been performed between the first histologic diagnosis and the time of registration as detailed below.
• Chest X-Ray, 2 view (or Chest CT, or positron emission tomography [PET]/CT) is mandatory
• Bone scans (with x-rays of abnormal areas) are required only if alanine aminotransferase (ALT), aspartate aminotransferase (AST) or Alkaline Phosphatase is elevated or if there are signs or symptoms of metastatic disease
• Abdominal imaging is required only if ALT, AST or Alkaline Phosphatase is elevated or if there are signs or symptoms of metastatic disease 2. Prior Treatment 2.1 All adjuvant or neoadjuvant chemotherapy, radiation, and surgery completed at least 21 days prior to registration. 2.2 All triple negative patients must receive chemotherapy of the treating physician's choice. 2.3 ER/PR+ patients must receive chemotherapy (of the treating physician's choice) unless Oncotype Dx or another genomic predictor score indicates that they are at low or intermediate risk of disease recurrence with endocrine therapy alone. 2.4 Patients may have breast reconstruction during protocol participation, but definitive breast cancer surgery must be completed at least 21 days prior to registration. Concomitant biologic therapy, hormonal therapy, and bisphosphonates are acceptable. 2.5 Surgical margins must be clear of invasive carcinoma. If there is microscopic residual ductal in situ disease present at lumpectomy or total mastectomy margins, further excision is highly recommended. If further excision is not undertaken, the subject may still be entered on study, provided that in addition to breast or chest wall irradiation, a boost to the tumor bed is delivered. In situ lobular disease at the margin is acceptable. 2.6 All subjects (both adjuvant and neoadjuvant) must have sentinel lymph node biopsy and/or axillary lymph node dissection. Sentinel lymph node biopsy alone is allowed in the following instances:
• Sentinel lymph node biopsy is negative: pN0
• Sentinel lymph node biopsy is positive for isolated tumor cells only: pN0 (i+)
• Clinically node negative, T1-2 tumors with sentinel lymph node biopsy positive in < 2 lymph nodes without matted nodes and undergoing breast conserving surgery and tangential whole breast irradiation, or undergoing mastectomy and chest wall irradiation.
• For patients who had a positive node prior to neoadjuvant chemotherapy, sentinel node alone is allowed after neoadjuvant therapy if:
• Sentinel node biopsy is negative after chemotherapy and either at least 2 sentinel nodes were removed or a clip was placed in the involved node prior to treatment.
• =< 2 lymph nodes are positive for cancer and the patient is participating in A011202
• All women who undergo breast conserving therapy must receive concomitant radiotherapy. Radiation after mastectomy is to be administered according to prespecified institutional guidelines. Radiation must be completed at least 21 days prior to registration.
• Patients with hormone receptor positive breast cancer as defined above must receive at least 5 years of adjuvant hormonal therapy in the form of tamoxifen or an aromatase inhibitor, alone or in combination with ovarian suppression. (NOTE: for patients with ER and PR staining in less than 5% of cells, hormonal therapy for at least 5 years is strongly recommended but not required). Hormonal therapy can be initiated prior to or during protocol therapy. 3. Participants must be women 4. Age ≥ 18 years 5. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1 6. Comorbid Conditions 6.1 No history of other malignancy within the past 4 years, except for malignancies with a >95% likelihood of cure (e.g. non-melanoma skin cancer, papillary thyroid cancer, in situ cervical cancer). Patients cannot have metastatic breast or other cancer. 6.2 No diabetes mellitus currently treated with insulin or sulfonylureas. 6.3 No history of serious digestive and/or absorptive problems, including inflammatory bowel disease and chronic diarrhea that preclude adherence to the study diet. 6.4 No history of severe cardiovascular, respiratory or musculoskeletal disease or joint problems that preclude moderate physical activity. Examples would include unstable angina, recent myocardial infarction, oxygen-dependent pulmonary disease, and osteoarthritis requiring imminent joint replacement. Moderate arthritis that does not preclude physical activity is not a reason for ineligibility. 6.5 No prior bariatric surgery or planning to undergo this procedure within the next 2 years after study registration. 6.6 No comorbid conditions that would cause life expectancy of less than 5 years. 6.7 No history of psychiatric disorders that would preclude participation in the study intervention (e.g. untreated major depression or psychosis, substance abuse, severe personality disorder) or prevent the patient from giving informed consent. 7. Other 7.1 BMI ≥27 kg/m2 documented within 56 days prior to study registration. The most recent BMI obtained must be used for eligibility. If most recent BMI is <27 then the patient is not eligible to enroll. 7.2 Self-reported ability to walk at least 2 blocks (at any pace). 7.3 Not participating in another weight loss, physical activity or dietary intervention clinical trial. Co-enrollment in some trials involving pharmacologic therapy is allowed. Participants in both arms are also allowed to pursue weight loss and physical activity programs on their own, as long as these programs are not provided as part of a clinical trial. 7.4 Able to read and comprehend English. Eligibility is restricted to individuals who can comprehend and read English given that participation in the study will require the ability to read lifestyle intervention materials and communicate with a coach through 42 phone calls over 2 years. The study team plans to make the intervention available in Spanish in the future.
Other: Health Education Program, Other: Weight Loss Intervention
Breast Carcinoma, Breast - Female
UT Southwestern; Children’s Health
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Higher Per Daily Treatment-Dose Radiation Therapy or Standard Per Daily Treatment Radiation Therapy in Treating Patients With Early-Stage Breast Cancer That Was Removed by Surgery

RATIONALE: It is not yet know whether higher per daily radiation therapy is equally as effective as standard per daily radiation therapy in treating breast cancer. PURPOSE: This randomized phase III trial studies how well an accelerated course of higher per daily radiation therapy with concomitant boost works compared to standard per daily radiation therapy with a sequential boost in treating patients with early-stage breast cancer that was removed by surgery.
Call 833-722-6237
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Assal Rahimi
115315
Female
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT01349322
STU 062011-039
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DISEASE CHARACTERISTICS:
• Pathologically proven diagnosis of breast cancer resected by lumpectomy and whole-breast irradiation (WBI) with boost without regional nodal irradiation planned
• Must meet one of the following three criteria:
• pStage I or II breast cancer AND at least one of the following:
• Age < 50 years or
• Positive axillary nodes or
• Lymphovascular space invasion (LVI) or
• At least 2 close resection margins (> 0 mm to ≤ 2 mm) or
• One close resection margin and extensive in-situ component (EIC) or
• Focally positive resection margins or
• Non-hormone-sensitive breast cancer (estrogen and progesterone receptor negative (ER- and PR-) or
• Grade III histology or
• Oncotype recurrence score > 25 or
• pStage 0 breast cancer with nuclear grade 3 ductal carcinoma in situ (DCIS) and patient age < 50 years or
• If multifocal breast cancer, then it must have been resected through a single lumpectomy incision with negative margins
• Breast-conserving surgery with margins defined as follows:
• Negative margins defined as no tumor at the resected specimen edge
• Close resection margins > 0 mm to ≤ 2 mm as follows:
• One close resection margin and EIC
• Two or more close resection margins
• A focally positive resection margin
• Allowable options for mandatory axillary staging include:
• Sentinel node biopsy alone (if sentinel node is negative, pN0, pN0[IHC-,+])
• Sentinel node biopsy alone, OR followed by axillary node dissection, for clinically node-negative patients as described below:
• Microscopic sentinel node (SN) positive (pN1mic)
• One or two SNs positive (pN1) without extracapsular extension
• Negative SN biopsy after neoadjuvant chemotherapy
• Axillary node dissection is required following SN biopsy with a minimum total of 6 axillary nodes if any of the following exist:
• For > 2 positive SN
• Any positive SN biopsy after neoadjuvant chemotherapy
• For clinically (by either imaging or examination) T3 disease
• For extracapsular extension
• Axillary dissection alone (with a minimum of 6 axillary nodes)
• CT-imaging of the ipsilateral breast within 28 days of study entry for the radiation treatment planning.
• Must be able to delineate on CT scan the extent of the target lumpectomy cavity for boost (placement of surgical clips to assist in treatment planning of the boost is strongly recommended)
• No clinical evidence for distant metastases, based upon the following minimum diagnostic workup:
• History/physical examination, including breast exam (inspection and palpation of the breasts) and documentation of weight and Zubrod Performance Status of 0-2 within 28 days prior to study entry
• A mammogram of both right and left breast within only 1 time point of 90 days of the diagnostic biopsy establishing the diagnosis
• No prior invasive or in-situ carcinoma of the breast (prior LCIS is eligible)
• No American Joint Committee on Cancer (AJCC) pathologic T4, N2 or N3, or M1 breast cancer
• Must not have two or more breast cancers that are not resectable through a single lumpectomy incision
• Must not be DCIS and ≥ 50 years old
• Must not be DCIS only (without an invasive component), nuclear grade 1 or 2 and < 50 years old
• No suspicious unresected microcalcification, densities, or palpable abnormalities (in the ipsilateral or contralateral breast) unless biopsied and found to be benign
• No non-epithelial breast malignancies such as sarcoma or lymphoma
• No Paget disease of the nipple
• No male breast cancer
• Breast implants allowed PATIENT CHARACTERISTICS:
• ANC ≥ 1,800/mm³
• Platelet count ≥ 75,000/mm³
• Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention to achieve Hgb ≥ 8.0 g/dL is acceptable)
• Negative urine or serum pregnancy test within 14 days of study entry
• Women of childbearing potential must not be pregnant or nursing and willing to use medically acceptable form of contraception during radiotherapy
• No prior invasive non-breast malignancy (except non-melanomatous skin cancer or carcinoma in situ of the cervix) unless disease free for a minimum of 5 years prior to study entry
• No severely active co-morbidity, defined as follows:
• Unstable angina and/or congestive heart failure requiring hospitalization within the last 6 months
• Transmural myocardial infarction within the past 6 months
• Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration
• Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before registration
• Hepatic insufficiency resulting in clinical jaundice and/or coagulation defects; note, however, that laboratory tests for liver function and coagulation parameters are not required for entry into this protocol
• Acquired Immune-Deficiency Syndrome (AIDS) based upon current CDC definition
• HIV testing is not required for entry into this protocol
• No active systemic lupus, erythematosus, or any history of scleroderma or dermatomyositis with active rash
• Medical, psychiatric, or other condition that would prevent the patient from receiving the protocol therapy or providing informed consent PRIOR CONCURRENT THERAPY:
• See Disease Characteristics
• Study entry must be within 50 days of last breast/axillary surgery and/or last chemotherapy
• No treatment plan that includes regional-node radiotherapy
• No prior radiotherapy to the breast or prior radiation to the region of the ipsilateral breast that would result in overlap of radiation therapy fields
• No intention to administer concurrent chemotherapy for current breast cancer
Radiation: Whole breast irradiation delivered by 3-dimensional conformal radiation therapy or intensity modulated radiation therapy, Radiation: Higher per daily radiation therapy, Radiation: Concurrent boost radiotherapy, Radiation: Standard per daily radiation therapy, Radiation: Sequential boost radiotherapy
Breast Cancer, Breast - Female
stage IA breast cancer, stage IB breast cancer, stage II breast cancer, estrogen receptor-negative breast cancer, estrogen receptor-positive breast cancer, progesterone receptor-negative breast cancer, progesterone receptor-positive breast cancer, ductal breast carcinoma in situ
UT Southwestern; Children’s Health
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Digital Tomosynthesis Mammography and Digital Mammography in Screening Patients for Breast Cancer

This randomized phase III trial studies digital tomosynthesis mammography and digital mammography in screening patients for breast cancer. Screening for breast cancer with tomosynthesis mammography may be superior to digital mammography for breast cancer screening and may help reduce the need for additional imaging or treatment.
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Walter Evans
12114
Female
45 Years to 74 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT03233191
STU 122017-066
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Inclusion Criteria:

• Women of childbearing potential must not be known to be pregnant or lactating
• Patients must be scheduled for, or have intent to schedule, a screening mammogram
• Patients must be able to tolerate digital breast tomosynthesis and full-field digital mammographic imaging required by protocol, to be performed at an American College of Radiology Imaging Network (ACRIN)-qualified facility
• Patients must be willing and able to provide a written informed consent
• Patients must not have symptoms or signs of benign or malignant breast disease (eg, nipple discharge, breast lump) warranting a diagnostic rather than a screening mammogram, and/or other imaging studies (eg, sonogram); patients with breast pain are eligible as long as other criteria are met
• Patients must not have had a screening mammogram within the last 11 months prior to date of randomization
• Patients must not have previous personal history of breast cancer including ductal carcinoma in situ
• Patients must not have breast enhancements (e.g., implants or injections)
• ANNUAL SCREENING REGIMEN ELIGIBILITY CHECK
• To be eligible for inclusion in the annual screening regimen one of the following three conditions must be met in addition to the eligibility criteria above:
• Patients are pre-menopausal; OR
• Post-menopausal aged 45-69 with any of the following three risks factors:
• Dense breasts (BIRADS density categories c-heterogeneously dense or d-extremely dense), or
• Family history of breast cancer (first degree relative with breast cancer), or, positive genetic testing for any deleterious genes that indicate an increased risk for breast cancer, or
• Currently on hormone therapy; OR
• Post-menopausal ages 70-74 with either of the following two risk factors:
• Dense breasts (BIRADS density categories c-heterogeneously dense or d-extremely dense), or
• Currently on hormone therapy
• Postmenopausal women are defined as those with their last menstrual period more than 12 months prior to study entry; for the purpose of defining menopausal status for women who have had surgical cessation of their periods, women who no longer have menses due to hysterectomy and oophorectomy will be considered postmenopausal; women who no longer have menses due to hysterectomy without oophorectomy will be considered premenopausal until age 52 and postmenopausal thereafter
• All other postmenopausal women are eligible for inclusion in the biennial screening regimen
• For those women who cannot be assigned to annual or biennial screening at the time of study entry and randomization because they are postmenopausal, have no family history or known deleterious breast cancer mutation, are not on hormone therapy AND have not had a prior mammogram, breast density will be determined by the radiologist?s recording of it at the time of interpretation of the first study screening examination, either DM or TM; for those who are randomized to TM, radiologists will assign BI-RADS density through review of the DM or synthetic DM portion of the TM examination; such women cannot be part of the planned stratification by screening frequency and are expected to represent far less than 1% of the Tomosynthesis Mammographic Imaging Screening Trial (TMIST) population
• Breast density will be determined by prior mammography reports, when available; all other risk factors used to determine patient eligibility for annual or biennial screening will be determined by subject self-report
Procedure: Digital Mammography, Procedure: Digital Tomosynthesis Mammography, Other: Laboratory Biomarker Analysis
Breast Screening, Breast - Female
Digital Mammography, Breast Tomography, Screening Mammography, TMIST
UT Southwestern
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Doxorubicin Hydrochloride, Cyclophosphamide, and Paclitaxel With or Without Bevacizumab in Treating Patients With Lymph Node-Positive or High-Risk, Lymph Node-Negative Breast Cancer

This randomized phase III trial studies doxorubicin hydrochloride, cyclophosphamide, and paclitaxel to see how well they work with or without bevacizumab in treating patients with cancer that has spread to the lymph nodes (lymph node-positive) or cancer that has not spread to the lymph nodes but is at high risk for returning (high-risk, lymph node-negative breast cancer). Drugs used in chemotherapy, such as doxorubicin hydrochloride, cyclophosphamide, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as bevacizumab, may interfere with the ability of tumor cells to grow and spread. Bevacizumab may also stop the growth of breast cancer by blocking blood flow to the tumor. Giving chemotherapy after surgery may kill any tumor cells that remain after surgery and help prevent the tumor from returning. It is not yet known whether doxorubicin hydrochloride, cyclophosphamide, and paclitaxel are more effective with or without bevacizumab.
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Barbara Haley
30339
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT00433511
STU 092010-096
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Inclusion Criteria:

• Patients must have histologically confirmed adenocarcinoma of the breast at significant risk of distant recurrence based on at least one of the following criteria:
• For axillary lymph node positive disease:
• Involvement of at least one sentinel or axillary lymph node on routine histologic examination; patients with negative sentinel nodes and negative axillary nodes or involvement only demonstrated by immunohistochemistry are not eligible unless they meet one of the other eligibility criteria below
• NOTE: consider intramammary nodes as equivalent to axillary nodes for the purposes of eligibility and stratification
• For axillary lymph node negative disease:
• Estrogen receptor (ER) negative tumor >= 1 cm
• ER+ tumor >= 5 cm regardless of recurrence score
• ER+ tumor >= 1 cm but < 5 cm with a recurrence score >= 11 (patients enrolled in the TAILORx trial are eligible)
• NOTE: axillary dissection is strongly encouraged in patients with lymph node involvement identified on sentinel node biopsy
• Patients must have completed definitive breast surgery including total mastectomy and axillary dissection (modified radical mastectomy), total mastectomy and sentinel node biopsy, breast conservation surgery and axillary dissection or breast conservation surgery and sentinel node biopsy
• NOTE: breast conservation surgery includes lumpectomy, partial mastectomy, and excisional biopsy
• Margins of breast conservation surgery or mastectomy must be histologically free of invasive breast cancer and ductal carcinoma in situ (DCIS); patients with resection margins positive for lobular carcinoma in situ (LCIS) are eligible
• Time from last surgery for breast cancer (breast conservation surgery, mastectomy, sentinel node biopsy, axillary dissection or re-excision of breast conservation surgery margins) to planned treatment start date must be > 28 days and =< 84 days
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Within =< 8 weeks prior to randomization: Absolute neutrophil count >= 1,000/mm^3
• Within =< 8 weeks prior to randomization: Platelet count >= 100,000/mm^3
• Within =< 8 weeks prior to randomization: Total bilirubin =< 1.5 mg/dL
• Within =< 8 weeks prior to randomization: Aspartate aminotransferase (AST) =< 2 times upper limit of normal(ULN)
• Within =< 8 weeks prior to randomization: Serum creatinine =< 1.5 mg/dL
• Within =< 8 weeks prior to randomization: Urine protein:creatinine ratio < 1.0 or 24-hour protein
• Within =< 8 weeks prior to randomization: Partial thromboplastin time (PTT) =< 1.5 times ULN
• Within =< 8 weeks prior to randomization: Left ventricle ejection fraction (LVEF) >= institutional limits of normal by multigated acquisition scan (MUGA) or echocardiogram (ECHO)
• Patients who have undergone breast conservation surgery must receive radiation; prior to randomization, the investigator must specify the planned radiation technique:
• Whole breast radiation (WBRT) after chemotherapy
• Accelerated partial breast radiation (APBI) after chemotherapy
• Accelerated partial breast radiation (APBI) prior to chemotherapy
• NOTE: if APBI was completed prior to study entry, day 1 of protocol therapy must be at least 4 weeks after the completion of APBI
• Post-mastectomy radiation therapy (RT) is required for all patients with a primary tumor of >= 5 cm or involvement of 4 or more lymph nodes; post-mastectomy RT may be administered at the investigator's discretion for all other mastectomy patients
• Patients with human epidermal growth factor receptor (HER)2 + (3+ by immunohistochemistry [IHC] or fluorescent in situ hybridization [FISH] ratio >= 2) breast cancer are not eligible
• Patients with synchronous bilateral breast cancer (diagnosed within one month) are eligible if the higher tumor, node, metastasis (TNM) stage tumor meets the eligibility criteria for this trial
• Patients must not have clinical evidence of inflammatory disease or fixed axillary nodes at diagnosis
• Patients must not have received prior cytotoxic chemotherapy or hormonal therapy for this breast cancer; prior treatment with an anthracycline, anthracenedione or taxane for any condition is not allowed
• NOTE: prior use of tamoxifen for chemoprevention is allowed but must be discontinued at study entry; similarly, prior raloxifene use is allowed but must be discontinued at study entry
• Patients must not have had any major surgical procedure within 28 days of planned treatment start date
• NOTE: non-operative biopsy or placement of a vascular access device is not considered a major surgery
• Patients may not have had placement of a vascular access device within 24 hours of planned day 1 of treatment
• Patients must not have clinically significant cardiovascular or cerebrovascular disease, including:
• Any history of
• Cerebrovascular disease including transient ischemic attack (TIA), stroke or subarachnoid hemorrhage
• Ischemic bowel
• Within the last 12 months
• Myocardial infarction
• Unstable angina
• New York Heart Association (NYHA) class II or greater congestive heart failure
• Grade II or greater peripheral vascular disease
• Uncontrolled hypertension defined as systolic blood pressure (SBP) > 160 or diastolic blood pressure (DBP) > 90
• Uncontrolled or clinically significant arrhythmia
• NOTE: blood pressure must be obtained within =< 8 weeks prior to randomization
• NOTE: patients with controlled atrial fibrillation are eligible
• Patients who require full-dose anticoagulation may enroll provided they meet the following criteria:
• The patient must have an in-range international normalized ratio (INR) (usually between 2 and 3) on a stable dose of warfarin or be on stable dose of low molecular weight (LMW) heparin
• The patient must not have active bleeding or pathological conditions that carry high risk of bleeding (e.g. varices)
• NOTE: prophylactic use of anticoagulants to maintain patency of a vascular access device is permitted
• Patients must not have a bleeding diathesis, hereditary or acquired bleeding disorder or coagulopathy
• Patients must not have a non-healing wound or fracture; patients with an abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to randomization are not eligible
• Patients must not have hypersensitivity to paclitaxel or drugs using the vehicle Cremophor, Chinese hamster ovary cell products or other recombinant human antibodies
• Women must not be pregnant or breast-feeding; all females of childbearing potential must have a blood or urine test within 7 days prior to randomization to rule out pregnancy
• Women of childbearing potential and sexually active males must use an accepted and effective method of contraception
Biological: Bevacizumab, Drug: Cyclophosphamide, Drug: Doxorubicin Hydrochloride, Other: Laboratory Biomarker Analysis, Drug: Paclitaxel, Other: Placebo Administration, Other: Quality-of-Life Assessment
Breast Adenocarcinoma, Breast - Female
Children’s Health
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Phase 1 / 2 Study of SAR439859 Single Agent and in Combination With Palbociclib in Postmenopausal Women With Estrogen Receptor Positive Advanced Breast Cancer

Primary Objectives: Dose Escalation: Part A (SAR439859 monotherapy); Part C (combination of SAR439859 with palbociclib) - To determine the maximum tolerated dose (MTD) and recommended dose (RD) of SAR439859 based on the dose-limiting toxicity (DLT) observance in monotherapy (Part A), and in combination with palbociclib (Part C) Dose Expansion: Part B (SAR439859 monotherapy) - To assess antitumor activity by Objective Response Rate (ORR) at the SAR439859 recommended dose in monotherapy Dose Expansion: Part D (combination of SAR439859 with palbociclib) - Overall safety profile of SAR439859 in combination with palbociclib Midazolam Drug-Drug Interaction Sub-Study: Part E - To assess the effect of SAR439859 on CYP3A enzyme activity using midazolam as a probe Secondary Objectives: - Overall safety profile of SAR439859 as monotherapy (Parts A, B, E), and in combination with palbociclib (Parts C, D) - Pharmacokinetic (PK) profile of SAR439859 as monotherapy (Parts A, B, E), and of SAR439859 in combination with palbociclib (Parts C, D), and of palbociclib in combination with SAR439859 (Parts C, D) - Antitumor activity of SAR439859 as monotherapy (Part A and E), and in combination with palbociclib (Part C and D) as well as the Clinical Benefit Rate (CBR: Complete Response [CR], Partial Response [PR] and Stable Disease [SD] ≥24 weeks) in Parts A, B, C, D and E - ORR and CBR (CR, PR and SD ≥24 weeks) in Parts B, D and E according to the estrogen receptor 1 (ESR1) gene mutational status (mutant and wild type) at baseline and in treatment - Time to first tumor response (CR or PR) in Parts B and D - Residual estrogen receptor (ER) availability with [(18)F] Fluoroestradiol Positron Emission Tomography (FES PET) scan (Part A) - To assess potential induction/inhibition effect of SAR439859 on CYP3A (Part A, B, E)
Call 833-722-6237
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Barbara Haley
30339
Female
18 Years and over
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT03284957
STU-2018-0077
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Inclusion criteria: Parts A, B, C, D and E:
• Patients must be postmenopausal women
• Histological diagnosis of breast adenocarcinoma
• Locally advanced or metastatic disease
• Either primary tumor or any metastatic site to be positive for Estrogen Receptors (ER+) and negative for HER2 (HER2-) receptor
• Patients previously treated with endocrine therapy for advanced disease: at least 6 months exposure to endocrine therapy (Patients with early progression on adjuvant endocrine therapy or who progressed on adjuvant endocrine therapy within 12 months after completion are eligible), and in part D, no more than 2 prior lines of endocrine therapy are allowed
• Patients previously treated with chemotherapy for advanced disease: no more than 3 prior chemotherapeutic regimens in Part A, and no more than 1 prior chemotherapeutic regimen in Parts B, C, D and E (including Antibody Drug Conjugates)
• Measurable lesion Exclusion criteria:
• Medical history or ongoing gastrointestinal disorders that could affect absorption of SAR439859 and/or palbociclib (including difficulties with swallowing capsules)
• Patient with any other cancer (except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer or any other cancer from which the patient has been disease free for >3 years)
• Patients with known brain metastases
• Treatment with anticancer agents (including investigational drugs) less than 2 weeks before first study treatment starts (less than 4 weeks if the anticancer agents were antibodies)
• Prior treatment with another selective ER down-regulator (SERD) (except fulvestrant) with a washout of at least 6 weeks prior to the first study drug administration
• Inadequate hematological and biochemical lab tests
• Patients with Gilbert disease
• Treatment with human immunodeficiency virus (HIV)-antiviral, antifungal and antioxidant agents less than 2 weeks before study treatment starts
• Treatment with strong and moderate cytochrome P450 (CYP) 3A or CYP2C8 inducers within 2 weeks before first study treatment
• Treatment with strong CYP3A inhibitors within 2 weeks before first study treatment starts
• More than one prior cyclin-dependent kinase (CDK) 4/6 inhibitor based therapy.
• No prior CDK4/6 exposure is required for patients with early progression on adjuvant endocrine therapy or who progressed on adjuvant endocrine therapy within 12 months after completion of adjuvant endocrine therapy Part A only:
• Patients with liver metastases only Part D only:
• Prior therapy with any selective CDK4/6 inhibitor, phosphoinositide 3-kinase (PI3K) inhibitors and mammalian target of rapamycin (mTOR) inhibitors Part E only:
• Any treatment with weak CYP3A inducer and all CYP3A inhibitors within 2 weeks before midazolam administration
• Any contraindications to midazolam (in accordance with the applicable label)
• Use of any herbal medicines 1 week, and grapefruit juice for 72 hours before midazolam administration and up to the end of PK sampling following the last midazolam administration
• Patients older than 60 years The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Drug: SAR439859, Drug: palbociclib, Drug: midazolam
Breast Cancer, Breast - Female
UT Southwestern
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Performance of Contrast-Enhanced Spectral Mammography to Assess Neoadjuvant Chemotherapy Response (CEDM)

This study is designed to investigate the diagnostic accuracy of Contrast Enhanced Spectral Mammography (CEDM) in predicting early neoadjuvant therapy response and pathologic complete response (pCR) compared to mammography. Patients diagnosed with invasive breast cancer with available mammography and ultrasound imaging are eligible for the study. Eligible patients will be imaged at baseline (before initiation of neoadjuvant chemotherapy or endocrine therapy), early (2-4 cycles of neoadjuvant therapy) and late (after completion of neoadjuvant chemotherapy or endocrine therapy) timepoints with mammography. CEDM will be done within 2 weeks of the specified timepoint. Additionally, a survey of subject experience with CEDM and other pre-operative imaging will be collected after CEDM is performed.
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Basak Dogan
162032
All
18 Years and over
Phase 4
This study is NOT accepting healthy volunteers
NCT04625517
STU-2019-0529
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Inclusion Criteria:

• Ipsilateral intact biopsy-proven breast cancer clinical stage T1-T4 (by imaging)
• Available mammography and ultrasound imaging of the existing index cancer, with orthogonal measurements
• Prior history of ipsilateral or contralateral breast cancer, presenting with a new primary or recurrent disease
• Patients who were determined to be candidates for either neoadjuvant chemotherapy or neoadjuvant endocrine therapy by the treating physician
• Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for days following completion of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Exclusion Criteria:

• History of ipsilateral mastectomy
• Women who already started neoadjuvant chemotherapy or endocrine therapy
• Woman who may be pregnant or nursing an infant
• Prior history of anaphylactic or anaphylactoid reaction to any contrast.
• Prior allergy to iodine or iodinated contrast.
• Impaired renal function measured by estimated glomerular filtration rate (eGFR) < 60 milliliters per minute.
• Patients with known distant metastasis.
Procedure: Digital Mammography, Drug: Low Osmolar Contrast Material, 300-399 Mg/Ml Iodine Concentration, Per Ml
Breast Cancer, Breast - Female
mammography, contrast enhanced spectral mammography
UT Southwestern
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S1207 Hormone Therapy With or Without Everolimus in Treating Patients With Breast Cancer (e3)

RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate, goserelin acetate, leuprolide acetate, anastrozole, letrozole, or exemestane, may fight breast cancer by lowering the amount of estrogen the body makes. Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet know whether hormone therapy is more effective when given with or without everolimus in treating breast cancer. PURPOSE: This randomized phase III trial studies how well giving hormone therapy together with or without everolimus work in treating patients with breast cancer.
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Nisha Unni
148963
All
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT01674140
STU 052016-023
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DISEASE CHARACTERISTICS:
• Patients must have a histologically confirmed diagnosis of invasive breast carcinoma with positive estrogen (ER)- and/or progesterone-receptor (PR) status, and negative human epidermal growth factor receptor (HER)2, for whom standard adjuvant endocrine therapy is planned
• ER and PR positivity must be assessed according to American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines as either ER or PR ≥ 1% positive nuclear staining
• HER2 test result negativity must be assessed as per ASCO/CAP 2013 guidelines using IHC, ISH or both. HER2 is negative if a single test (or all tests) performed in a tumor specimen show: 1. IHC negative (0 or 1+) 2. ISH negative using single probe or dual probe. If IHC is 2+, evaluation for gene amplification (ISH) must be performed and the ISH must be negative; ISH is not required if IHC is 0 or 1+. HER2 equivocal is not eligible.
• Patients must not have metastatic breast cancer (stage IV disease); patients with multifocal, multicentric, and synchronous bilateral, and primary inflammatory breast cancers are allowed
• Multifocal disease is defined as more than one invasive cancer < 2 cm from the largest lesion within the same breast quadrant
• Multicentric disease is defined as more than one invasive cancer ≥ 2 cm from the largest lesion within the same breast quadrant or more than one lesion in different quadrants
• Synchronous bilateral disease is defined as invasive breast cancer with positive lymph nodes (axillary or intramammary) in at least one breast, diagnosed within 30 days of each other
• Patients must be high risk by belonging to one of the following risk groups:
• Completion of adjuvant chemotherapy and pathologically negative axillary nodes, and a tumor measuring ≥ 2 cm in greatest diameter, and an Oncotype DX® recurrence score (RS) > 25 (completed as standard of care). Patients with micrometastases as the only nodal involvement (pN1mi) are eligible, and will be categorized as node-negative.
• Completion of adjuvant chemotherapy, and pathologically 1-3 positive lymph nodes, and either an Oncotype DX® RS > 25 (screened via S1007 or otherwise) or tumor tissue with pathological Grade III following local practice. If Oncotype DX is done, then RS must be > 25. If the test is not done, but the patient has Grade III disease then the patient is eligible and Oncotype DX does not need to be performed.
• Completion of adjuvant chemotherapy and pathologically 4 or more positive lymph nodes.
• Completion of neoadjuvant chemotherapy and 1 or more positive nodes pathologically determined prior to or after chemotherapy
• Patients must have completed either breast-conserving surgery or total mastectomy, with negative margins and appropriate axillary staging; a negative margin is defined as no evidence of tumor or ductal carcinoma in situ (DCIS) at the line of resection; additional operative procedures may be performed to obtain clear margins
• Patients who had breast-conserving surgery must have completed whole-breast radiation; use of regional nodal-basin radiation will be at the discretion of the investigator according to institutional guidelines
• Patients with ≥ 4 positive lymph nodes must have completed breast/chest wall and nodal-basin radiation therapy according to standard-of-care guidelines before randomization; omission of radiation therapy is not allowed in this high-risk population of patients
• Patients must be registered no sooner than 21 days after completion of radiation therapy and must have recovered (≤ grade 1) from any of the effects of radiation
• Patients must have undergone axillary staging by sentinel-node biopsy or axillary lymph node dissection (ALND)
• For patients with 1-3 positive lymph nodes, sentinel-node biopsy alone is allowed provided that the patient completed either whole-breast or chest-wall radiation and the primary tumor is < 5 cm
• All patients with ≥ 4 positive lymph nodes must have completed ALND (with or without prior sentinel-node biopsy) PATIENT CHARACTERISTICS:
• Absolute Neutrophil Count ≥ 1,500/mL
• Hemoglobin ≥ 9 g/dL
• Platelet count ≥ 100,000/mL
• Bilirubin ≤ 1.5 mg/dL (≤ 3.0 mg/dL if due to Gilbert syndrome)
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 times institutional upper limit of normal (IULN)
• Alkaline phosphatase ≤ 1.5 times IULN
• Serum creatinine level ≤ IULN
• Fasting cholesterol ≤ 300 mg/dL and triglycerides ≤ 2.5 times IULN; patients may be on lipid-lowering agents to reach these values
• Patients must have a performance status of 0-2 by Zubrod criteria
• Patients must not have any grade III/IV cardiac disease as defined by the New York Heart Association Criteria (i.e., patients with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia
• Patients previously diagnosed with diabetes must not have uncontrolled diabetes (defined as a hemoglobin [Hg] A1C > 7% within 28 days prior to registration)
• Patients known to be human immunodeficiency virus (HIV) positive may be enrolled if baseline CD4 count is > 500 cells/mm³ and they are not taking anti-retroviral therapy
• Patients with known hepatitis are not eligible
• Patients must not have any known uncontrolled, underlying pulmonary disease
• Patients must be able to take oral medications
• Patients may not have any impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of blinded drug (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)
• Patients must not be pregnant or nursing
• Women/men of reproductive potential must have agreed to use an effective non-hormonal contraceptive method during and for 8 weeks after completion of study therapy
• In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy, or bilateral tubal ligation; corresponding procedures for men include castration, vasectomy, and barrier-contractive devices
• If at any point a previously celibate patient chooses to become heterosexually active during the protocol therapy, he/she is responsible for beginning contraceptive measures
• No other prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for 5 years PRIOR CONCURRENT THERAPY:
• See Disease Characteristics
• Patients must have completed standard neoadjuvant or adjuvant chemotherapy prior to randomization; completion of chemotherapy will be determined by the treating oncologist, but should include a minimum of 4 cycles (a cycle of weekly paclitaxel is considered 3 doses); patients must be registered within 42 weeks after the last dose of chemotherapy; patients may have started endocrine therapy at any time after the diagnosis of the current breast cancer
• Patients must not be receiving or planning to receive trastuzumab
• Concurrent bisphosphonate therapy is allowed
• Patients must not have prior exposure to mTOR inhibitors (rapamycin, everolimus, temsirolimus, deforolimus)
• Patients must not have prior treatment with any investigational drug within the preceding 28 days and must not be planning to receive any other investigational drug for the duration of the study
• Patients must not be planning to receive any other anticancer drug for the duration of the study
• Patients must not have an organ allograft or other history of immune compromise; patients must not be receiving chronic, systemic treatment with corticosteroids or other immunosuppressive agent; topical or inhaled corticosteroids are allowed
• Patients must not have received immunization with an attenuated live vaccine (e.g., intranasal influenza, measles, mumps, and rubella [MMR], oral polio, varicella, zoster, yellow fever, and Bacillus Calmette-Guérin [BCG] vaccines) within seven days prior to registration nor have plans to receive such vaccination while on protocol treatment
• Patients must not have taken within 14 days prior to registration, be taking, nor plan to take while on protocol treatment, strong cytochrome P450 3A4 (CYP3A4) inhibitors and/or CYP3A4 inducers
Drug: anastrozole, Drug: everolimus, Drug: exemestane, Drug: goserelin acetate, Drug: letrozole, Drug: leuprolide acetate, Drug: tamoxifen citrate, Other: placebo
Breast Cancer, Breast - Female, Breast - Male
estrogen receptor-positive breast cancer, HER2-negative breast cancer, stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, progesterone receptor-positive breast cancer, male breast cancer
UT Southwestern; Children’s Health
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Cyberknife® Partial Breast Irradiation (PBI) for Early Stage Breast Cancer

By using stereotactic body radiation therapy (SBRT) delivered with the Cyberknife system®, the current protocol attempts to mimic or improve the excellent local control rates seen in treatment of early stage breast cancer while attempting to increase convenience, limit invasiveness, decrease toxicity, and improve cosmesis compared to other methods of radiation treatment.
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Assal Rahimi
115315
Female
18 Years to 99 Years old
Phase 1
This study is NOT accepting healthy volunteers
NCT01162200
STU 072010-015
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Inclusion Criteria:

• DCIS or invasive ductal, medullary, papillary, mucinous (colloid), or tubular histologies.
• Eligible patients must have appropriate staging studies identifying them as AJCC stage T1 or T2 (≤3 cm) treated with lumpectomy and axillary node dissection with at least 6 nodes sampled or sentinel node biopsy. Patients with up to 3 positive nodes without microscopic or macroscopic evidence of extracapsular extension are eligible.
• The patient's Zubrod performance status must be 0-2.
• Patients must be ≥ 18 years of age.
• If chemotherapy is planned, it must begin no earlier than two weeks following completion of radiation therapy.
• Unifocal breast cancer (no evidence of gross multifocal disease, multicentric, or bilateral disease.
• Negative margins after lumpectomy (re-excision for initial positive margins is allowed-negative margins defined as >2 mm clear of tumor in all directions).
• Negative post- lumpectomy mammography if malignancy-associated microcalcifications were initially present.
• The target lumpectomy cavity must be clearly delineated.
• Patients must complete appropriate pretreatment evaluation, including post-lumpectomy mammogram if microcalcifications were initially present to confirm complete removal.
Exclusion Criteria:

• Evidence of suspicious microcalcifications in the breast prior to start of radiation.
• Patients with history of collagen vascular disease, specifically dermatomyositis with a CPK level above normal or active skin rash, systemic lupus erythematosis, or scleroderma.
• Patients with 4 or more histologically positive axillary nodes if axillary dissection is performed.
• Patients with distant metastases.
• Patients with invasive or extensive in-situ lobular carcinoma or non-epithelial breast malignancies such as sarcoma or lymphoma.
• Patients with multicentric gross disease defined as tumors in different quadrants of the breast or tumor separated by at least 4 cm or other clinically or radiographically suspicious areas in the ipsilateral breast unless confirmed to be negative for malignancy or biopsy.
• Patients must not have any palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes unless there is histologic confirmation that these nodes are negative for tumor.
• Any previously treated contralateral invasive breast carcinoma or synchronous contralateral breast carcinoma.
• Prior non-hormonal therapy or radiation therapy for the current breast cancer or hormonal therapy for > 28 days after diagnosis or refusal to discontinue hormonal therapy.
• Patients with Paget's disease of the nipple
• Patients with prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years (e.g., carcinoma in situ of the breast, oral cavity, or cervix are all permissible).
• Patients with severe, active co-morbidity.
• Patients with psychiatric or addictive disorders that, in the opinion of the investigator, would preclude obtaining informed consent.
• Patients who are pregnant or lactating.
• Previous breast radiation on either side or thoracic radiation on the ipsilateral side..
Radiation: Stereotactic Body Radiation Therapy
Early Stage Breast Cancer, Breast - Female
Children’s Health
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Phase I Dose Escalation of Single Fraction Adjuvant Stereotactic Body Partial Breast Irradiation Early Stage Breast CA

Radiation, Stereotactic Body Radiation Therapy.
Call 833-722-6237
canceranswerline@utsouthwestern.edu
Assal Rahimi
115315
Female
18 Years and over
Phase 1
This study is NOT accepting healthy volunteers
NCT02685332
STU 062015-085
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Inclusion Criteria:

• Ductal carcinoma in situ (DCIS) or invasive epithelial (ductal, medullary, papillary, mucinous (colloid), or tubular histologies
• Willing and able to provide consent
• Age >=18 years.
• Performance status Eastern Cooperative Oncology Group (ECOG) 0-2
• Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 90 days following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
• Appropriate staging studies identifying as American Joint Committee on Cancer (AJCC) stage 0, I, or II breast cancer. If stage II, the tumor size must be 3 cm or less.
• Surgical treatment of the breast with lumpectomy Clinical Target Volume (CTV) margin up to 5 cm in maximum dimension with histologically confirmed margins free of tumor (negative margins defined as no tumor on ink in all directions). Re-excision of surgical margins is permitted.
• Gross disease within the breast must be unifocal. (Patients with microscopic multifocality are eligible as long as the total extent of tumor, gross and microscopic, occupies a volume with greatest dimension 3 cm or less)
• Patients with invasive disease are required to have axillary staging including: sentinel node biopsy alone if sentinel node is negative, sentinel node biopsy followed by axillary dissection with a minimum of 6 axillary nodes sampled if sentinel node is positive, or axillary dissection alone (with a minimum of 6 axillary nodes). Patients with DCIS are not required to have axillary staging.
• Patients with a history of non-breast invasive malignancies are eligible if they have been disease-free for 3 or more years prior to entry into the study
Exclusion Criteria:

• T2 (>3.0 cm), T3, stage III, or stage IV breast cancer
• More than 3 histologically positive axillary lymph nodes or axillary lymph nodes with microscopic or macroscopic extracapsular extension.
• Positive non-axillary sentinel nodes or evidence of suspicious supraclavicular, infraclavicular, or internal mammary nodes by imaging or physical exam, unless biopsied and found to be negative for tumor.
• Evidence by physical examination or mammography of other suspicious masses, densities, or microcalcifications in either breast, unless biopsied and found to be benign.
• Non epithelial breast malignancies such as sarcoma or lymphoma.
• Multicentric gross breast carcinoma (either DCIS or invasive cancer) or microscopic breast carcinoma occupying a volume with maximum dimensions of more than 3 centimeters.
• Synchronous bilateral invasive or non-invasive breast cancer.
• Paget's disease of the nipple.
• Previous breast radiation on ipsilateral side or thoracic radiation on the ipsilateral side.
• Treatment plan that includes regional nodal irradiation.
• Any prior treatment with radiation therapy or chemotherapy for the currently diagnosed breast cancer prior to registration. Endocrine therapy may be given but not within 28 days prior to study entry and must be stopped if the patient will be receiving chemotherapy until completion of chemotherapy. Patients must discontinue any hormonal agents such as raloxifene, tamoxifen, or other selective estrogen receptor modulators prior to registration.
• Patients with collagen vascular disease, specifically dermatomyositis with a Creatine phosphokinase (CPK) level above normal or active skin rash, systemic lupus erythematosis, or scleroderma.
• Pregnancy or lactation at the time of registration. For women of childbearing age, they must agree to use effective contraceptive methods such as condom/diaphragm and spermicidal foam, intrauterine device, or prescription birth control pills.
• Patients with severe co-extensive comorbidities or significant psychiatric illness.
Radiation: Stereotactic Radiation
Early Stage Breast Cancer, Breast - Female
UT Southwestern; Children’s Health
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