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Platinum Based Chemotherapy or Capecitabine in Treating Patients With Residual Triple-Negative Basal-Like Breast Cancer Following Neoadjuvant Chemotherapy
This randomized phase III trial studies how well cisplatin or carboplatin (platinum based
chemotherapy) works compared to capecitabine in treating patients with remaining (residual)
basal-like triple-negative breast cancer following chemotherapy after surgery (neoadjuvant).
Drugs used in chemotherapy, such as cisplatin, carboplatin and capecitabine, 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. It is not yet known whether cisplatin
or carboplatin is more effective than capecitabine in treating patients with residual triple
negative basal-like breast cancer.
• ELIGIBILITY CRITERIA FOR SCREENING AND MOLECULAR PROFILING (STEP 0)
• Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 within 2 weeks
prior to screening
• Female and male patients must have histologically confirmed invasive breast cancer
that meets the following criteria:
• Clinical stage II-III (American Joint Committee on Cancer [AJCC] 7th edition) at
diagnosis, based on initial evaluation by clinical examination and/or breast
imaging; no metastatic disease allowed
• ER- and PR- should meet one of the following criteria:
• =< 10% cells stain positive, with weak intensity score (equivalent to Allred
score =< 3)
• =< 1% cells stain positive, with weak or intermediate intensity score
(equivalent to Allred score =< 3)
• HER2 negative (not eligible for anti-HER2 therapy) will be defined as:
• Immunohistochemistry (IHC) 0, 1+ without in situ hybridization (ISH)
HER2/neu chromosome 17 ratio OR
• IHC 2+ and ISH HER2/neu chromosome 17 ratio non-amplified with ratio less
than 2.0 and if reported average HER2 copy number < 6 signals/cells OR
• ISH HER2/neu chromosome 17 ratio non-amplified with ratio less than 2.0 and
if reported average HER2 copy number < 6 signals/cells without IHC
• NOTE: Patients that originally present with synchronous bilateral tumors are
eligible provided both tumors are TNBC, and at least one of them fulfills
the remainder eligibility criteria of the protocol; multifocal or
multicentric breast cancers are eligible as long as all tumors fulfill
eligibility criteria
• NOTE: Patients that have a discrepancy in ER/PR/HER2 status between original
diagnosis and surgical specimen (if ER/PR/HER2 status were repeated) are not
eligible for study participation (i.e. ER/PR/HER2 has to fulfill above
criteria in both scenarios)
• Patients must have completed neoadjuvant taxane +/- anthracycline; patients must NOT
have received cisplatin or carboplatin or capecitabine as part of their neoadjuvant
therapy regimen
• NOTE: Patients who received preoperative therapy as part of a clinical trial may
enroll
• NOTE: Patients that were not able to complete their planned neoadjuvant
chemotherapy for any reason (i.e. toxicities, etc.) are eligible to participate
as long as no further systemic standard of care therapy is planned by the
treating physician
• Must have completed definitive resection of primary tumor
• Negative margins for both invasive and ductal carcinoma in situ (DCIS) are
desirable, however patients with positive margins may enroll if the treatment
team believes no further surgery is possible and patient has received
radiotherapy; patients with margins positive for lobular carcinoma in situ (LCIS)
are eligible
• Either mastectomy or breast conserving surgery (including lumpectomy or partial
mastectomy) is acceptable
• Sentinel node biopsy either pre or post neoadjuvant chemotherapy (i.e. at the
time of definitive surgery) are allowed; axillary dissection is encouraged in
patients with lymph node involvement, but is not mandatory
• Post neoadjuvant chemotherapy, patients must be found to have residual invasive cancer
in the breast at the time of definitive surgery; residual cancer is defined as a
contiguous focus of residual invasive cancer, in the breast, measuring >= 1 cm in
diameter, and with more than minimal cellularity, as per local pathologist
determination; this is required due to constraints in deoxyribonucleic acid (DNA)
extraction for PAM50 analysis
• NOTE: The presence of ductal carcinoma in situ (DCIS) without invasion does not
qualify as residual invasive disease in the breast
• NOTE: Despite lymph node involvement if residual invasive cancer in the breast is
< 1 cm in diameter patients are not eligible for participation
• Radiotherapy may be given before or after protocol treatment per standard of care
guidelines; when radiotherapy is planned prior to protocol treatment administration,
patients may be registered and screened while receiving radiation
• Post-mastectomy radiotherapy is required for all patients with the following:
• Primary tumor >= 5 cm (prior to neoadjuvant chemotherapy [clinically] or at
the time of definitive surgery) or involvement of 4 or more lymph nodes at
the time of definitive surgery
• For patients with primary tumors < 5 cm or with < 4 involved lymph nodes
prior to neoadjuvant chemotherapy and at the time of definitive surgery,
provision of post-mastectomy radiotherapy is at the discretion of the
treating physician
• Radiation of regional nodal basins is at the discretion of the treating
radiation oncologist
• NOTE: Breast radiotherapy (whole breast or partial) is required for patients who
underwent breast-conserving therapy, including lumpectomy or partial mastectomy
• Hemoglobin (Hgb) > 9.0 g/dL
• Platelets > 100,000 mm^3
• Absolute neutrophil count (ANC) > 1500 mm^3
• Calculated creatinine clearance of > 50 mL/min using the Cockcroft-Gault formula
• Bilirubin =< 1.5 x ULN upper limit of normal (except in patients with documented
Gilbert?s disease, who must have a total bilirubin =< 3.0 mg/dL)
• Aspartate aminotransferase (AST, serum glutamic oxaloacetic transaminase [SGOT]) =<
2.5 x upper limit of normal (ULN)
• Alanine aminotransferase (ALT, serum glutamate pyruvate transaminase [SGPT]) =< 2.5 x
ULN
• No history of TNBC invasive breast cancer within 5 years of enrollment, no concurrent
malignancies of any sort
• No clinically significant infections as judged by the treating investigator
• Patients with active >= Common Terminology Criteria for Adverse Events (CTCAE) version
(v.) 4 grade 2 neuropathy are ineligible
• Adjuvant chemotherapy after surgery other than that specified in this protocol is not
allowed; luteinizing hormone-releasing hormone (LHRH) agonists and adjuvant
bisphosphonate or denosumab use is allowed
• Patients must have archived formalin-fixed paraffin-embedded (FFPE) tumor tissue
specimen from the residual disease on the definitive surgical specimen available for
PAM50 analysis for stratification
• Tumor tissue specimen from the definitive surgery has been collected and is ready
to ship to the ECOG-American College of Radiology Imaging Network (ACRIN) Central
Biorepository and Pathology Facility (CBPF) within 21 weeks post-surgery
• The Molecular Diagnostics Laboratory (MDL) at MD Anderson Cancer Center will
perform the PAM50 analysis and notify the ECOG-American College of Radiology
Imaging Network (ACRIN) operations office within three (3) weeks of receipt of
the tumor tissue specimen via secure electronic messaging to the ECOG-ACRIN
database; results will not be reported to the submitting institution
• NOTE: Tissue must be submitted any time during screening period, even if patient
is getting radiation
• NOTE: Every effort should be made to submit the tumor tissue specimen to the
ECOG-ACRIN CBPF immediately
• ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): No specific timeframe between
registration and randomization needs to be observed, as long as:
• Patients randomized to the chemotherapy arms have their cycle 1/ day 1 (platinum
based or capecitabine) start within 3 weeks (15 working days) following
randomization date
• Randomization occurs no more than 24 weeks from surgery date
• ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Must have PAM50 analysis by digital
mRNA quantitation on the formalin-fixed paraffin-embedded tumor tissue specimen (FFPE)
of the residual disease in the breast or axilla resected at the time of definitive
surgery completed
• ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): ECOG performance status 0 or 1 within
2 weeks prior to randomization
• ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Radiotherapy may be given before or
after protocol treatment. when radiotherapy is planned prior to protocol treatment
administration, patients must have completed adjuvant radiotherapy >= 2 weeks prior to
randomization for protocol therapy, if applicable
• ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Patients must have completed
treatment with any investigational agent >= 30 days prior to randomization for
protocol therapy, if applicable
• ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Patients must be randomized within 24
weeks from surgery
• ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Women must not be pregnant or
breast-feeding; all females of childbearing potential must have a blood test or urine
study within 2 weeks prior to randomization to rule out pregnancy
• A female of childbearing potential is any woman, regardless of sexual orientation
or whether they have undergone tubal ligation, who meets the following criteria:
1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been
naturally postmenopausal for at least 24 consecutive months (i.e., has had menses
at any time in the preceding 24 consecutive months
• ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Women of childbearing potential and
sexually active males must be strongly advised to use an accepted and effective method
of contraception or to abstain from sexual intercourse for the duration of their
participation in the study
• ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Hemoglobin (Hgb) > 9.0 g/dL
• ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Platelets > 100,000 mm^3
• ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Absolute neutrophil count (ANC) >
1500 mm^3
• ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): International normalized ratio (INR)
=< 3 (to be done/tested only for subjects on warfarin)
• ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Calculated creatinine clearance of >
50 mL/min using the Cockcroft-Gault formula
• ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Bilirubin =< 1.5 x ULN (except in
patients with documented Gilbert?s disease, who must have a total bilirubin =< 3.0
mg/dL)
• ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Aspartate aminotransferase (AST,
SGOT) =< 2.5 x ULN
• ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Alanine aminotransferase (ALT, SGPT)
=< 2.5 x ULN
HER2/Neu Negative, Stage IIA Breast Cancer, Stage IIB Breast Cancer, Stage IIIB Breast Cancer, Estrogen Receptor Negative, Progesterone Receptor Negative, Invasive Breast Carcinoma, Stage IIIA Breast Cancer, Stage IIIC Breast Cancer, Triple-Negative Breast Carcinoma, Stage III Breast Cancer, Stage II Breast Cancer, Breast - Female, Breast - Male
Letrozole in Post-Menopausal Patients With Operable Hormone-Sensitive Breast Cancer
A short pre-surgical non-therapeutic trial involving postmenopausal women with newly
diagnosed eR+, HeR2-negative operable breast cancers. After undergoing a core needle biopsy
for tissue acquisition, study participants will take a 7- to 56-day (1-8 weeks) course of
letrozole in accordance with standard of care. They will then undergo definitive surgical
resection of their primary tumor (mastectomy vs lumpectomy) as per standard of care
guidelines.
1. Eligibility waivers are not permitted. Subjects must meet all of the inclusion and
exclusion criteria to be registered to the study. Study treatment may not begin until
a subject is registered.
2. Patients must provide informed written consent
3. ECOG performance status 0-1.
4. Clinical stage operable I, II or III invasive mammary carcinoma, which is ER-positive
by IHC and HER2-negative by Herceptest (0 or 1+) or not amplified by FISH as per
routine clinical testing Patients who have measurable residual tumor at the primary
site Patients who will undergo surgical treatment with either segmental resection or
total mastectomy
5. Measurable tumor i. Measurable disease: a mass that can be reproducibly measured by
physical exam and calipers or ultrasound and is at least 1 cm in size
6. The pathology report from the initial diagnosis has been reviewed by either UTSW or
Parkland Hospital, Department of Pathology and meets eligibility criteria. Available
core biopsies from the time of diagnosis have been requested. These may include the
paraffin block or sections from the paraffin-embedded tumor blocks.
7. Post-menopausal female subjects ≥18 years of age, as defined by any of the following:
• Subjects at least 55 years of age;
• Subjects under 55 years of age and amenorrhoeic for at least 12 months or
follicle-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;
• Prior bilateral oophorectomy or prior radiation castration with amenorrhea for at
least 6 months.
• (There is no upper age limit for enrollment to this study)
8. No prior chemotherapy for this primary breast cancer.
9. Patients with a prior history of contralateral breast cancer are eligible if they have
no evidence of recurrence of their initial primary breast cancer.
10. 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 21 days prior to study
enrollment.
11. Subjects must have ended hormone replacement therapy (HRT) (e.g., conjugated estrogens
tablets, USP, [Premarin]), at least 7 days prior to receiving the first dose of
randomized therapy.
12. Patients must have adequate hepatic and renal function. All tests must be obtained
less than 4 weeks from study entry. This includes:
1. Creatinine <1.5X upper limits of normal
2. Bilirubin, SGOT, SGPT <1.5X upper limits of normal
13. Able to swallow and retain oral medication
Exclusion Criteria:
1. Patients with locally advanced disease who are candidates for other preoperative
chemotherapy at the time of initial evaluation. This may include patients with locally
advanced disease such as:
• Inflammatory breast cancer (T4d)
• Fixed axillary lymph node metastases (N2)
• Metastasis to ipsilateral internal mammary node (N3)
2. Locally recurrent breast cancer
3. Evidence of distant metastatic disease (i.e. lung, liver, bone, brain, etc.)
4. Serious medical illness that in the judgment of the treating physician places the
patient at high risk of operative mortality.
5. Severe uncontrolled malabsorption condition or disease (i.e. grade II/III diarrhea,
severe malnutrition, short gut syndrome)
6. Dementia, altered mental status, or any psychiatric condition that would prohibit the
understanding or rendering of informed consent.
7. Use of an investigational drug within 30 days or 5 half-lives, whichever is longer,
preceding the first dose of letrozole.
Atezolizumab Before and/or With Chemoradiotherapy in Immune System Activation in Patients With Node Positive Stage IB2, II, IIIB, or IVA Cervical Cancer
This phase I trial studies how well atezolizumab before and/or with standard of care
chemoradiotherapy works in immune system activation in patients with stage IB2, II, IIIB, or
IVA cervical cancer that has spread to the lymph nodes. Immunotherapy with monoclonal
antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and
may interfere with the ability of tumor cells to grow and spread. Giving atezolizumab before
and/or with chemoradiotherapy may lower the chance of tumors growing or spreading.
• Patients with histologically confirmed newly diagnosed advanced cervical cancer
(squamous cell carcinoma, adenocarcinoma, and adenosquamous cell carcinoma):
Federation of Gynecology and Obstetrics (FIGO) clinical stages IB2/IIA with positive
para-aortic nodes, or FIGO clinical stages IIB/IIIB/IVA with positive pelvic or
para-aortic lymph nodes (PALN). Pelvic or PALN nodal status confirmed by PET/CT scan
or fine needle biopsy or extra peritoneal biopsy or laparoscopic biopsy. The PALN must
be inferior to the T12/L1 interspace
• Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
• Leukocytes >= 2,500/mcL
• Absolute neutrophil count >= 1,500/mcL
• Platelets >= 100,000/mcL (> 50,000 for patients with hematologic malignancies)
• Hemoglobin >= 8 g/dL (can be transfused with red blood cells pre-study)
• Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (however, patients
with known Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolled)
• Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase
[SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])
=< 3 x ULN (AST and/or ALT =< 5 x ULN for patients with liver involvement)
• Alkaline phosphatase =< 2.5 x ULN (=< 5 x ULN for patients with documented liver
involvement or bone metastases)
• Creatinine clearance =< 1.5 mg/dL to receive weekly cisplatin
• Patients whose serum creatinine is between 1.5 and 1.9 mg/dL are eligible for
cisplatin if there is no hydronephrosis and the estimated creatinine clearance
(CCr) is >= 30 ml/min. For the purpose of estimating the CCr, the formula of
Cockcroft and Gault for females should be used
• International normalized ratio (INR) and activated partial thromboplastin time (aPTT)
=< 1.5 x ULN (this applies only to patients who do not receive therapeutic
anticoagulation; patients receiving therapeutic anticoagulation, such as
low-molecular-weight heparin or warfarin, should be on a stable dose)
• Patient does not have a known allergy to cisplatin or compounds of similar biologic
composition
• Patient is not actively breastfeeding (or has agreed to discontinue breastfeeding
before the initiation or protocol therapy)
• Thyroid-stimulating hormone (TSH) within normal limits or normal free T4 in those with
abnormal TSH
• Ability to understand and the willingness to sign a written informed consent document
• Patients positive for human immunodeficiency virus (HIV) are allowed on study, but
HIV-positive patients must have:
• A stable regimen of highly active anti-retroviral therapy (HAART)
• No requirement for concurrent antibiotics or antifungal agents for the prevention
of opportunistic infections
• A CD4 count above 250 cells/mcL and an undetectable HIV viral load on standard
polymerase chain reaction (PCR)-based tests
Exclusion Criteria:
• Patients who have received prior radiation therapy to the pelvis or abdominal cavity,
PALN radiation, or previous therapy of any kind for this malignancy or pelvic, PALN,
or abdominal radiation for any prior malignancy
• Patients with PALN nodal metastasis above the T12/L1 interspace
• Patients who had a radical hysterectomy with positive PALNs are not eligible
• Patients with prior allogeneic bone marrow transplantation or prior solid organ
transplantation
• Patients previously treated with systemic anticancer therapy (e.g., chemotherapy,
targeted therapy, immunotherapy) within 3 years prior to entering the study
• Treatment with systemic immunosuppressive medications (including, but not limited to,
prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor
necrosis factor [anti-TNF] agents) within 2 weeks prior to cycle 1, day 1
• Patients who have received acute, low dose, systemic immunosuppressant
medications (e.g., a one-time dose of dexamethasone for nausea or steroids as CT
scan contrast premedication) may be enrolled
• The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone)
for patients with orthostatic hypotension or adrenocortical insufficiency is
allowed
• Known hypersensitivity to Chinese hamster ovary cell products or other recombinant
human antibodies
• History of severe allergic, anaphylactic, or other hypersensitivity reactions to
chimeric or humanized antibodies or fusion proteins
• Patients requiring treatment with a RANKL inhibitor (e.g., denosumab) who cannot
discontinue it before treatment with atezolizumab
• Known clinically significant liver disease, including active viral, alcoholic, or
other hepatitis; cirrhosis; fatty liver; and inherited liver disease
• Patients with past or resolved hepatitis B infection (defined as having a
negative hepatitis B surface antigen [HBsAg] test and a positive anti-HBc
[antibody to hepatitis B core antigen] antibody test) are eligible
• Patients positive for hepatitis C virus (HCV) antibody
• History or risk of autoimmune disease, including but not limited to systemic lupus
erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis
associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's
syndrome, Bell's palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune
thyroid disease, vasculitis, or glomerulonephritis
• Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid
replacement hormone are eligible
• Patients with controlled type 1 diabetes mellitus on a stable insulin regimen or
type 2 diabetes mellitus are eligible
• Patients with eczema, psoriasis, lichen simplex chronicus or vitiligo with
dermatologic manifestations only (e.g., patients with psoriatic arthritis would
be excluded) are permitted provided that they meet the following conditions:
• Patients with psoriasis must have a baseline ophthalmologic exam to rule out
ocular manifestations
• Rash must cover less than 10% of body surface area (BSA)
• Disease is well controlled at baseline and only requiring low potency
topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%,
fluocinolone 0.01%, desonide 0.05%, alclometasone dipropionate 0.05%)
• No acute exacerbations of underlying condition within the last 12 months
(not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate,
retinoids, biologic agents, oral calcineurin inhibitors; high potency or
steroids)
• History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced),
organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing
pneumonia, etc.), or evidence of active pneumonitis on screening chest computed
tomography (CT) scan. History of radiation pneumonitis in the radiation field
(fibrosis) is permitted
• Patients with active tuberculosis (TB) are excluded
• Severe infections within 4 weeks prior to cycle 1, day 1, including but not limited to
hospitalization for complications of infection, bacteremia, or severe pneumonia
• Signs or symptoms of infection within 2 weeks prior to cycle 1, day 1
• Received intravenous (IV) antibiotics within 2 weeks prior to cycle 1, day 1. Patients
receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection
or chronic obstructive pulmonary disease) are eligible
• Major surgical procedure within 28 days prior to cycle 1, day 1 or anticipation of
need for a major surgical procedure during the course of the study
• Administration of a live, attenuated vaccine within 4 weeks before cycle 1, day 1 or
anticipation that such a live, attenuated vaccine will be required during the study
and up to 5 months after the last dose of atezolizumab
• Influenza vaccination should be given during influenza season only (approximately
October to March). Patients must not receive live, attenuated influenza vaccine
within 4 weeks prior to cycle 1, day 1 or at any time during the 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 would limit compliance with
study requirements
• Severe, active co-morbidity defined as follows:
• Current (within 28 days of cycle 1, day 1) signs and/or symptoms of bowel
obstruction
• Patients who require parental hydration and/or nutrition
• Patients who require drainage gastrostomy tube
• Evidence of bleeding diathesis or clinically significant coagulopathy
• Serious, non-healing or dehiscing wound, active ulcer or untreated bone fracture
• History of hemoptysis (>= 1/2 teaspoon of bright red blood per episode) within 1
month of study enrollment
• Significant cardiovascular or cerebrovascular disease including:
• Uncontrolled hypertension (systolic blood pressure [SBP] >= 150; diastolic blood
pressure [DBP] >= 90)
• History of myocardial infarction within 6 months
• Unstable angina
• New York Heart Association functional classification II, III or IV
• Baseline ejection fraction =< 50% as assessed by echocardiogram or multigated
acquisition scan (MUGA)
• Cerebral vascular accident (CVA) or transient ischemic attack (TIA) within 6
months
• Significant vascular disease (e.g., aortic aneurysm, requiring surgical repair or
peripheral arterial thrombosis) within 6 months
• History of abdominal/pelvic or tracheoesophageal fistula or gastrointestinal
perforation and/or abscess within 6 months prior to initiation of treatment
• If patients are of child-bearing potential and do not agree to use two forms of birth
control then they are ineligible
• Patients who have had a hysterectomy or are planning to have an adjuvant hysterectomy
following radiation as part of their cervical cancer treatment are ineligible
• Patients scheduled to be treated with adjuvant consolidation chemotherapy at the
conclusion of their standard chemoradiation
• Pregnant women are excluded from this study because radiation therapy has 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 atezolizumab, breastfeeding should be discontinued if the mother is
treated with atezolizumab
• 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 the 5 months (150 days) after the last
dose of the study agent. Should a woman become pregnant or suspect she is pregnant
while she or her partner is participating in this study, she should inform her
treating physician immediately
• Patients taking bisphosphonate therapy for symptomatic hypercalcemia. Use of
bisphosphonate therapy for other reasons (e.g. osteoporosis) is allowed
• Patients with known primary central nervous system (CNS) malignancy or CNS metastases
are excluded
• Patients with a prior known history of vesicovaginal, enterovaginal or colovaginal
fistula
Olaparib With or Without Atezolizumab in Treating Patients With Locally Advanced Unresectable or Metastatic Non-HER2-Positive Breast Cancer
This randomized phase II trial studies how well olaparib with or without atezolizumab work in
treating patients with non-HER2-positive breast cancer that has spread from its original site
of growth to nearby tissues or lymph nodes and is not amenable to surgical resection (locally
advanced unresectable) or has spread to other places in the body (metastatic). Olaparib is an
inhibitor of PARP, an enzyme that helps repair deoxyribonucleic acid (DNA) when it becomes
damaged. Blocking PARP may help keep cancer cells from repairing their damaged DNA, causing
them to die. PARP inhibitors are a type of targeted therapy. Immunotherapy with monoclonal
antibodies, such as atezolizumab, may help the body's immune system attack the tumor, and may
interfere with the ability of tumor cells to grow and spread. It is not known whether giving
olaparib with or without atezolizumab will work better in patients with non-HER2-positive
breast cancer.
• Patients must have histologically documented unresectable locally advanced or
metastatic non-HER2-positive breast cancer and a known BRCA 1/2 mutation present; both
germline and somatic mutations are acceptable, however somatic mutations must be
identified by tumor sequencing and not blood; patients with BRCA mutations of unknown
significance are not allowed
• Patients must have measurable disease, defined as at least one lesion that can be
accurately measured in at least one dimension (longest diameter to be recorded for
non-nodal lesions and short axis for nodal lesions) as >= 20 mm (>= 2 cm) by chest
x-ray or as >= 10 mm (>= 1 cm) with computed tomography (CT) scan, magnetic resonance
imaging (MRI), or calipers by clinical exam
• Prior chemotherapy is allowed, including platinum therapy; patients must not have
received chemotherapy for 4 weeks prior to the initiation of study treatment and must
have recovery =< grade 1 from any adverse events from any prior chemotherapy (other
than alopecia); patients must not have had nitrosoureas or mitomycin C for 6 weeks
prior to the initiation of study treatment
• Prior radiation therapy is allowed; patients must not have received minimal radiation
therapy (=< 5% of their total marrow volume) within 3 weeks prior to the initiation of
study treatment; otherwise, patients must not have received radiation therapy (> 5% of
their total marrow volume) within 4 weeks prior to the initiation of study treatment;
patients who have received prior radiation to 50% or more of their total marrow volume
will be excluded
• Patients who have received prior treatment with anti-CTLA-4 may be enrolled, provided
the following requirements are met: minimum of 12 weeks from the first dose of
anti-CTLA-4 and > 6 weeks from the last dose, and no history of severe immune-related
adverse effects from anti-CTLA-4 (National Cancer Institute [NCI] Common Terminology
Criteria for Adverse Events [CTCAE] grade 3 and 4)
• Treatment with systemic immunosuppressive medications (including, but not limited to,
prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor
necrosis factor [anti-TNF] agents) is allowed, provided the following is met: minimum
of 2 weeks prior to cycle 1, day 1; patients who have received acute, low dose,
systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for
nausea) may be enrolled; the use of corticosteroids and mineralocorticoids (e.g.,
fludrocortisone) for patients with orthostatic hypotension or adrenocortical
insufficiency is allowed
• Prior treatment with systemic immunostimulatory agents (including, but not limited to,
interferon [IFN]-alpha or interleukin [IL]-2) is allowed, provided the following is
met: minimum of 6 weeks prior to cycle 1, day 1
• Patients taking bisphosphonate therapy for symptomatic hypercalcemia are NOT allowed;
use of bisphosphonate therapy for other reasons (e.g., bone metastasis or
osteoporosis) is allowed
• Prior hormone therapy is allowed; patients must not have received hormone therapy for
breast cancer for 2 weeks prior to the initiation of study treatment and must have
recovery =< grade 1 from any adverse events related to these therapies (other than
alopecia)
• Prior experimental (non-Food and Drug Administration [FDA] approved) therapies and
immunotherapies are allowed; patients must not have received these therapies for 4
weeks prior to the initiation of study treatment and must have recovery =< grade 1
from any adverse events of these therapies (other than alopecia); prior treatment with
any PARP inhibitor or any anti-PD-1/anti-PD-L1 antibody is NOT allowed
• Other therapies (e.g. targeted therapy such as cyclin-dependent kinase [CDK]
inhibitors): patients should have recovered to =< grade 1 drug related toxicity; they
must have completed therapy for either a total of duration equivalent to 5 half-lives
of the drug or 28 days, whichever is shorter
• Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
• Life expectancy of greater than 6 months
• Absolute neutrophil count >= 1,500/mcL
• Leukocytes >= 3,000/mcL
• Platelets >= 100,000/mcL
• Hemoglobin >= 8 g/dL
• Total bilirubin =< 1.5 x upper limit of normal (ULN) (however, patients with known
Gilbert disease who have serum bilirubin level =< 3 x ULN may be enrolled)
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase
[SGOT])/alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase [SGPT]) =<
2.5 x upper limit of normal (ULN) if no liver metastasis; =< 5 x upper ULN if liver
metastasis present
• Alkaline phosphatase =< 2.5 x ULN (=< 5 x ULN for patients with documented liver
involvement or bone metastases)
• Creatinine clearance >= 51 mL/min/1.73 m^2 by Cockcroft-Gault
• International normalized ratio (INR) and activated partial thromboplastin time (aPTT)
=< 1.5 x ULN (this applies only to patients who do not receive therapeutic
anticoagulation; patients receiving therapeutic anticoagulation, such as
low-molecular-weight heparin or warfarin, should be on a stable dose)
• No features suggestive of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML)
on peripheral blood smear when performed as clinically indicated
• Patients must have tumors determined to be easily accessible for biopsy and must be
willing to have serial biopsies (with a third biopsy upon evidence of disease
progression)
• Administration of atezolizumab and/or olaparib may have an adverse effect on pregnancy
and poses a risk to the human fetus, including embryo-lethality; women of
child-bearing potential and men must agree to use highly effective contraception prior
to study entry, for the duration of study participation, and for at least 5 months
(150 days) after the last dose of study agent; should a woman become pregnant or
suspect she is pregnant while she or her partner is participating in this study, she
should inform her treating physician immediately; men treated or enrolled on this
protocol must also agree to use two highly effective forms of contraception in
combination prior to the study, for the duration of study participation, and for at
least 5 months (150 days) after completion of atezolizumab and/or olaparib
administration; women of child-bearing potential: negative serum pregnancy test within
28 days of study treatment and confirmed prior to treatment on day 1; postmenopausal
or evidence of non-childbearing status for women of childbearing potential;
postmenopausal is defined as:
• Amenorrheic for 1 year or more following cessation of exogenous hormonal
treatments
• Luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels in the
post-menopausal range for women under 50
• Radiation-induced oophorectomy with last menses > 1 year ago
• Chemotherapy-induced menopause with > 1 year interval since last menses
• Surgical sterilization (bilateral oophorectomy or hysterectomy)
• Ability to understand and the willingness to sign a written informed consent document
• Subject is able to swallow and retain oral medication and does not have uncontrolled
emesis or gastrointestinal disorders likely to interfere with absorption of the study
medication
• Patients crossing over from monotherapy to combination therapy do not have to be fully
rescreened; however, they do need to meet performance status, organ function, and
blood parameters and not meet any of the exclusion criteria
• Patients positive for human immunodeficiency virus (HIV) are NOT excluded from this
study, but HIV-positive patients must have:
• A stable regimen of highly active anti-retroviral therapy (HAART)
• No requirement for concurrent antibiotics or antifungal agents for the prevention
of opportunistic infections
• A CD4 count above 250 cells/mcL and an undetectable HIV viral load on standard
polymerase chain reaction (PCR)-based test
Exclusion Criteria:
• Patients with prior allogeneic bone marrow transplantation, double umbilical cord
blood transplantation (dUCBT) or prior solid organ transplantation
• Patients with known brain metastases should be excluded from this clinical trial
except as those described below, because of their poor prognosis and because they
often develop progressive neurologic dysfunction that would confound the evaluation of
neurologic and other adverse events
• Patients with known primary central nervous system (CNS) malignancy or symptomatic CNS
metastases are excluded, with the following exceptions:
• Patients with asymptomatic untreated CNS disease may be enrolled, provided all of
the following criteria are met:
• Evaluable or measurable disease outside the CNS
• No metastases to brain stem, midbrain, pons, medulla, cerebellum, or within
10 mm of the optic apparatus (optic nerves and chiasm)
• No history of intracranial hemorrhage unless it is confined within a lesion
previously noted and secondary to gamma knife or another equivalent
radiologic therapeutic
• No history of spinal cord hemorrhage
• No ongoing requirement for dexamethasone for CNS disease; patients on a
stable dose of anticonvulsants are permitted
• No neurosurgical resection or brain biopsy within 28 days prior to cycle 1,
day 1
• Patients with asymptomatic treated CNS metastases may be enrolled, provided all
the criteria listed above are met as well as the following:
• Radiographic demonstration of improvement upon the completion of CNS
directed therapy and no evidence of interim progression between the
completion of CNS directed therapy and the screening radiographic study
• No stereotactic radiation or whole-brain radiation within 28 days prior to
cycle 1, day 1
• Screening CNS radiographic study >= 4 weeks from completion of radiotherapy
and >= 2 weeks from discontinuation of corticosteroids
• Known hypersensitivity to Chinese hamster ovary cell products or other recombinant
human antibodies
• History of severe allergic, anaphylactic, or other hypersensitivity reactions to
chimeric or humanized antibodies or fusion proteins
• History of allergic reactions attributed to compounds of similar chemical or biologic
composition to olaparib and atezolizumab; patients with a known hypersensitivity to
olaparib or any of the excipients of the product
• Prior treatment with any PARP inhibitor or any anti-PD-1/anti-PD-L1 antibody
• Known clinically significant liver disease, including active viral, alcoholic, or
other hepatitis; cirrhosis; fatty liver; and inherited liver disease
• Patients with past or resolved hepatitis B infection (defined as having a
negative hepatitis B surface antigen [HBsAg] test and a positive anti-HBc
[antibody to hepatitis B core antigen] antibody test) are eligible
• Patients positive for hepatitis C virus (HCV) antibody are eligible only if PCR
is negative for HCV RNA
• History or risk of autoimmune disease, including, but not limited to, systemic lupus
erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis
associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's
syndrome, Bell's palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune
thyroid disease, vasculitis, lichen sclerosis, or glomerulonephritis
• Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid
replacement hormone may be eligible
• Patients with controlled type 1 diabetes mellitus on a stable insulin regimen may
be eligible
• Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with
dermatologic manifestations only (e.g., patients with psoriatic arthritis would
be excluded) are permitted provided that they meet the following conditions:
• Patients with psoriasis must have a baseline ophthalmologic exam to rule out
ocular manifestations
• Rash must cover less than 10% of body surface area (BSA)
• Disease is well controlled at baseline and only requiring low potency
topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%,
fluocinolone 0.01%, desonide 0.05%, alclometasone dipropionate 0.05%)
• No acute exacerbations of underlying condition within the last 12 months
(not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate,
retinoids, biologic agents, oral calcineurin inhibitors; high potency or
oral steroids)
• History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced),
organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing
pneumonia, etc.), or evidence of active pneumonitis on screening chest computed
tomography (CT) scan; history of radiation pneumonitis in the radiation field
(fibrosis) is permitted if recovered
• Major surgical procedure within 28 days prior to cycle 1, day 1 and patients must have
recovered from any effects of any major surgery; anticipation of need for a major
surgical procedure during the course of the study
• Administration of a live, attenuated vaccine within 4 weeks before cycle 1, day 1 or
anticipation that such a live, attenuated vaccine will be required during the study
and up to 5 months after the last dose of atezolizumab
• Influenza vaccination should be given during influenza season only (approximately
October to March); patients must not receive live, attenuated influenza vaccine
within 4 weeks prior to cycle 1, day 1 or at any time during the study
• Patients considered a poor medical risk due to a serious, uncontrolled medical
disorder, non-malignant systemic disease or active, uncontrolled infection; examples
include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 3
months) myocardial infarction, unstable spinal cord compression, superior vena cava
syndrome, symptomatic congestive heart failure, unstable angina pectoris, extensive
interstitial bilateral lung disease on high resolution computed tomography (HRCT) scan
or any psychiatric disorder that prohibits obtaining informed consent and would limit
compliance with study requirements
• Pregnant women are excluded from this study because olaparib and atezolizumab are have
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 olaparib and atezolizumab, breastfeeding should be discontinued if the
mother is treated with olaparib and atezolizumab
• Any prior grade >= 3 immune-related adverse event (irAE) while receiving any previous
immunotherapy agent, or any unresolved irAE > grade 1
• Patients with active seizures or a history of uncontrolled seizure disorder, including
focal or generalized seizure within the past year
• Patients requiring treatment with a RANKL inhibitor (e.g. denosumab) who cannot
discontinue it before treatment with atezolizumab
• Resting electrocardiogram (ECG) with corrected QT (QTc) > 470
Stage IV Breast Cancer AJCC v6 and v7, Stage IIIB Breast Cancer AJCC v7, Stage IIIC Breast Cancer AJCC v7, Stage III Breast Cancer AJCC v7, Stage IIIA Breast Cancer AJCC v7, Metastatic Breast Carcinoma, Locally Advanced Unresectable Breast Carcinoma, Breast - Female
Tranexamic Acid for Prevention of Hemorrhage in Cesarean Delivery (TXA)
The investigators prepared a novel study of tranexamic acid (TXA) designed to estimate the
quantity of blood loss in women undergoing elective repeat cesarean deliveries. This is the
first trial to utilize a prophylactic dose of TXA prior to incision followed by a subsequent
prophylactic dose at placental delivery in obstetric patients undergoing scheduled cesareans.
The purpose of this study is to quantify blood loss during uncomplicated repeat cesarean
deliveries with and without TXA. The central hypothesis is that TXA administration reduces
blood loss and fibrinolysis in women undergoing repeat cesarean sections.
Call 214-648-5005 studyfinder@utsouthwestern.edu
Olutoyosi Ogunkua
138932
Female
18 Years and over
Phase 2/Phase 3
This study is also accepting healthy volunteers
NCT03856164
STU-2018-0315
Show full eligibility criteria
Hide eligibility criteria
Inclusion Criteria:
1. Intrauterine pregnancy
2. Age ≥ 18
3. Gestation age ≥ 37 weeks 0 days
4. Scheduled cesarean delivery
5. Second or third cesarean delivery
6. Singleton pregnancy
Exclusion Criteria:
1. First cesarean delivery
2. Four or more cesarean deliveries
3. Intrauterine fetal death
4. Fetal anomalies
5. Documented coagulopathy (Elevated Prothrombin Time (PT), Elevated Partial
Thromboplastin Time (PTT), Elevated International Normalized Ratio (INR))
6. Thrombocytopenia (Platelet count < 100k)
7. Internal bleeding, external bleeding, easy bruising
8. History of thrombotic event
9. Hypertension
10. Diagnosis of renal insufficiency (Creatinine> 1 mg/dL)
11. Insulin-treated diabetes
12. Suspected morbidly adherent placenta
13. Placenta previa
14. Multiple Gestations
15. BMI ≥ 50
16. Hematocrit ≤ 25
17. Blood transfusion within 24 hours prior to cesarean delivery
18. History of abnormal bleeding or blood disorder
19. Planned general anesthesia
Drug: Tranexamic Acid, Drug: Placebo
Blood Loss, Post Partum Hemorrhage, Fibrinolysis, Hemorrhage
A Study of LY3484356 in Participants With Advanced or Metastatic Breast Cancer or Endometrial Cancer (EMBER)
The reason for this study is to see if the study drug LY3484356 alone or in combination with
other anticancer therapies is safe and effective in participants with advanced or metastatic
breast cancer or endometrial cancer.
All study parts:
• Participants must be willing to provide adequate archival tissue sample
• Participants must be willing to use highly effective birth control
• Participants must have adequate organ function
• Participants must be able to swallow capsules
Dose escalation- Participants must have one of the following:
• Parts A and B: ER+ HER2- breast cancer with evidence of locally advanced unresectable
or metastatic disease who have had the following:
• Part A: may have had up to 1 prior regimen of any kind for in the advanced/metastatic
setting and no prior cyclin-dependent kinase 4/6 (CDK4/6) inhibitor therapy.
• Part B: may have had up to 2 prior regimens, no more than 1 of which may be endocrine
therapy in the advanced/metastatic setting, and must have received a prior CDK4/6
inhibitor
• Cohort E4: No prior everolimus.
• Cohort E5: No prior alpelisib and must have a phosphatidylinositol 3-kinase catalytic
α (PIK3Cα) mutation as determined by local testing.
• Part C: ER+, human epidermal growth factor receptor 2 positive (HER2+) breast cancer
with evidence of locally advanced unresectable or metastatic disease who have had at
least 2 HER2-directed therapies for advanced disease and prior trastuzumab,
pertuzumab, and TDM-1 required in any setting.
• Part D: ER+, EEC that has progressed after platinum containing chemotherapy and no
prior fulvestrant or aromatase inhibitor therapy.
Participants with ER+/HER2- breast cancer enrolled in this study must have had evidence of
clinical benefit while on endocrine therapy for at least 24 months in the adjuvant setting
or at least 6 months in the advanced/metastatic setting or have untreated de novo
metastatic breast cancer
Exclusion Criteria:
• Participants must not have certain infections such as hepatitis or tuberculosis or HIV
that are not well controlled
• Participants must not have another serious medical condition
• Participants must not have cancer of the central nervous system that is unstable
• Participants must not be pregnant or breastfeeding
Testing the Addition of a New Anti-Cancer Drug, Triapine, to the Usual Chemotherapy Treatment (Cisplatin) During Radiation Therapy for Advanced-stage Cervical and Vaginal Cancers
This randomized phase III trial studies radiation therapy and cisplatin with triapine to see
how well they work compared to the standard radiation therapy and cisplatin alone in treating
patients with newly diagnosed stage IB2, II, or IIIB-IVA cervical cancer or stage II-IVA
vaginal cancer. Radiation therapy uses high energy protons to kill tumor cells and shrink
tumors. Drugs used in chemotherapy, such as cisplatin, 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. Triapine may stop the growth of tumor cells by blocking some of
the enzymes needed for cell growth. It is not yet known whether radiation therapy and
cisplatin are more effective with triapine in treating cervical or vaginal cancer.
• Patient has a new, unrated histologic diagnosis of stage IB2 (> 4 cm), II, IIIB or IVA
squamous, adenocarcinoma, or adenosquamous carcinoma of the uterine cervix or stage
II-IVA squamous, adenocarcinoma, or adenosquamous carcinoma of the vagina not amenable
to curative surgical resection alone; the presence or absence of para-aortic lymph
node metastasis will be based on pre-therapy 18F-FDG PET/CT; NOTE: if the baseline
18F-FDG PET/CT identifies hypermetabolic para-aortic disease, such patients will NOT
be eligible; the patient must be able to tolerate imaging requirements of an 18F-FDG
PET/CT scan
• Patient must provide study specific informed consent prior to study entry
• Patient must have a Gynecologic Oncology Group (GOG) performance status of 0, 1, or 2
or equivalent
• Absolute neutrophil count > 1,500/uL
• Platelets > 100,000/uL
• Hemoglobin > 10 g/dL
• Total bilirubin < 2.0 mg/dL
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase
[SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])
< 2.5 X institutional upper limit of normal
• Prothrombin time (PT)/activated partial thromboplastin time (aPTT) < 1.5 X
institutional upper limit of normal
• Creatinine =< 1.5 mg/dL to receive weekly cisplatin
• Patients whose serum creatinine is between 1.5 and 1.9 mg/dL are eligible for
cisplatin if the estimated creatinine clearance (CCr) is >= 30 ml/min; for the
purpose of estimating the CCr, the formula of Cockcroft and Gault for females
should be used
• Patient does not have uncontrolled diabetes mellitus (i.e., fasting blood glucose >
200 mg/dL)
• Patient has a life expectancy of greater than 20 weeks
• Patient does not have known brain metastases (testing optional)
• Patient does not have known human immunodeficiency virus syndrome (HIV, testing
optional); known HIV-positive patients receiving combination antiretroviral therapy
are ineligible because of the potential for pharmacokinetic interactions with triapine
• Patient does not have a known allergy to compounds of similar or biologic composition
as triapine
• Patient does not have known glucose-6-phosphate dehydrogenase (G6PD) deficiency as the
condition interferes with triapine antidote metabolism (G6PD testing optional)
• Patient is not actively breastfeeding (or has agreed to discontinue breastfeeding
before the initiation of protocol therapy)
Exclusion Criteria:
• Patient has another concurrent active invasive malignancy
• Patient has had a prior invasive malignancy diagnosed within the last three years
(except [1] non-melanoma skin cancer or [2] prior in situ carcinoma of the cervix);
patients are excluded if they have received prior pelvic radiotherapy for any reason
that would contribute radiation dose that would exceed tolerance of normal tissues at
the discretion of the treating physician
• Patient has uncontrolled intercurrent illness including, but not limited to,
symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction
within six months of protocol initiation, cardiac arrhythmia within six months of
protocol initiation; known inadequately controlled hypertension; clinically
significant pulmonary disease including dyspnea at rest, or patients requiring
supplemental oxygen, or poor pulmonary reserve; or clinically significant renal
function impairment (baseline serum creatinine > 2 mg/dL); or psychiatric
illness/social situations that would limit compliance with study requirements
• Patient is receiving another investigational agent for the treatment of cancer
• Patient is currently pregnant
• Patient does not agree to use two forms of birth control if they are of child-bearing
potential
• Patients who have had a hysterectomy or are planning to have an adjuvant hysterectomy
following radiation as part of their cervical cancer treatment are ineligible
• Patients scheduled to be treated with adjuvant consolidation chemotherapy or other
anti-neoplastic therapy at the conclusion of their standard chemoradiation
• Patients with self-reported or known diagnosis of G6PD deficiency
• Patients with vaginal cancer may have previously undergone a hysterectomy for various
indications; patients with vaginal cancer who underwent a hysterectomy for treatment
of cervical cancer less than five years prior to their diagnosis of vaginal cancer are
ineligible
Cervical Adenocarcinoma, Cervical Adenosquamous Carcinoma, Cervical Squamous Cell Carcinoma, Not Otherwise Specified, Vaginal Adenocarcinoma, Vaginal Squamous Cell Carcinoma, Not Otherwise Specified, Vaginal Adenosquamous Carcinoma, Stage IB2 Cervical Cancer AJCC v6 and v7, Stage II Cervical Cancer AJCC v7, Stage II Vaginal Cancer AJCC v6 and v7, Stage IIA Cervical Cancer AJCC v7, Stage IIB Cervical Cancer AJCC v6 and v7, Stage III Vaginal Cancer AJCC v6 and v7, Stage IIIB Cervical Cancer AJCC v6 and v7, Stage IVA Cervical Cancer AJCC v6 and v7, Stage IVA Vaginal Cancer AJCC v6 and v7
Studying the Physical Function and Quality of Life Before and After Surgery in Patients With Stage I Cervical Cancer
This clinical trial studies the physical function and quality-of-life before and after
surgery in patients with stage I cervical cancer. Studying quality-of-life in patients
undergoing surgery for cervical cancer may help determine the intermediate-term and long-term
effects of surgery.
• Patient must consent for the appropriate surgery
• Patients with a histologic diagnosis of squamous cell carcinoma, adenocarcinoma, or
adenosquamous cell carcinoma of the cervix, stage IA1 (lymph-vascular space invasion
[LVSI]+), IA2, and IB1 (tumor size [maximum visible or palpable]) =< 2 cm), any grade
• All patients must have undergone a cone biopsy or loop electrosurgical excision
procedure (LEEP); depth of invasion must be =< 10 mm
• Patients must have no evidence of metastasis on positron emission tomography (PET)
scan or magnetic resonance imaging (MRI) or computed tomography (CT) scan of the
pelvis and chest imaging
• Patients who have met the pre-entry requirements
• Patients must have signed an approved informed consent and authorization permitting
release of personal health information
• Patient must have Gynecologic Oncology Group (GOG) performance status of 0, 1, or 2
Exclusion Criteria:
• Patients with stage IA1 disease who are LVSI negative
• Patients with stage IB1 with tumor size (maximum visible or palpable) > 2 cm
• Patients with >= stage IB2 disease
• Patients with clear cell or neuroendocrine cell types
• Patients with depth of invasion > 10 mm on first cone biopsy (or LEEP)
• Patients with a history of other invasive malignancies, with the exception of
non-melanoma skin cancer, are excluded if there is any evidence of other malignancy
being present within the last five years; patients are also excluded if their previous
cancer treatment contraindicates this protocol therapy
Phase 1/2a Evaluation of Adding AL3818 to Standard Platinum-Based Chemotherapy in Subjects With Recurrent or Metastatic Endometrial, Ovarian, Fallopian, Primary Peritoneal or Cervical Carcinoma (AL3818-US-002) (AL3818)
This trial is a Phase 1b/2a trial designed to evaluate the safety and efficacy of adding oral
AL3818 to standard platinum-based chemotherapy concurrently and continued as a maintenance
therapy for up to 12 months.
• Female ≥ 18 years
• Previously histologically proven diagnosis of
a. Endometrial Cancer: recurrent or persistent endometrial carcinoma refractory to
conventional therapy or established treatments with the following histologic
epithelial cell types i. Endometrioid adenocarcinoma, serous adenocarcinoma,
undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma,
adenocarcinoma not otherwise specified, mucinous adenocarcinoma, squamous cell
carcinoma, and transitional cell carcinoma b. Ovarian Cancer: recurrent or persistent
ovarian or primary peritoneal cancer refractory to established treatments with the
following histologic epithelial cell types i. Endometrioid adenocarcinoma, serous
adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed
epithelial carcinoma, adenocarcinoma not otherwise specified.
c. Cervical cancer: squamous cell carcinoma of the cervix refractory to conventional
therapy or established treatments with the following histologic epithelial cell types:
i. Squamous cell carcinoma, adenosquamous carcinoma or adenocarcinoma Measurable
disease defined as at least one lesion that can be accurately measured in at least one
dimension (longest dimension to be recorded). Each lesion must be ≥ 20mm when measured
by conventional techniques, including palpation, plain x-ray, CT, and MRI or ≥ 10mm
when measured by spiral CT.
• Life expectancy ≥ 3 months
• Able to take orally administered study medication
• Must sign approved informed consent and authorization permitting release of personal
health information.
• Patient must have adequate:
1. Bone marrow function: absolute neutrophil count (ANC) ≥ 1,500/mm^3, equivalent to
Common Toxicity Criteria (CTC) grade 1, platelets ≥ 100,000/mm^3
2. Renal function: creatinine ≤ 1.5 x institutional upper limit normal (ULN), CTC
grade 1. Note: If creatinine is > 1.5 x ULN, creatinine clearance must be > 50
mL/min.
3. Hepatic function: bilirubin ≤ 1.5 x ULN (CTC grade 1) or ≤ 3.0 x ULN for subjects
with Gilbert Syndrome; AST and ALT ≤ 3.0 ×ULN.
4. Coagulation profile: PT such that international normalized ratio (INR) is ≤ 1.55
(or an in-range INR, usually between 2 and 3, if a patient is on a stable dose of
therapeutic warfarin or low molecular weight heparin) and a PTT < 1.2 times
control.
5. ECOG performance ≤ 2
• Patient of child-bearing potential must agree to use contraceptive measures starting 1
week before the administration of the first dose of AL3818 until 4 weeks after
discontinuing study drug and have a negative serum pregnancy test prior to study entry
and cannot be lactating.
• Ability and willingness to comply with the study protocol for the duration of the
study and with follow-up procedures.
Exclusion Criteria:
• Patients with serious, non-healing wound, ulcer or bone fracture.
• Patients with active bleeding or pathologic conditions that carry high risk of
bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major
vessels.
• Patient with history or evidence upon physical examination of CNS disease, including
primary brain tumor, seizures not controlled with standard medical therapy, any brain
metastases or history of cerebrovascular accident (CVA, stroke) transient ischemic
attack (TIA) or subarachnoid hemorrhage within 6 months of the first date of treatment
on this study.
a. Patients with metastatic CNS tumors may participate in this trial, if the patient
is > 4 weeks from therapy completion (including radiation and/or surgery), is
clinically stable at the time of study entry and is not receiving corticosteroid
therapy.
• Patients with proteinuria: patients discovered to have a urine protein of 1+ on
dipstick or ≥ 30 mg/dl at baseline should undergo a 24-hour urine collection, which
must be an adequate collection and must demonstrate < 1000 mg protein/24 hours to
allow participation in the study.
• Patients with clinically significant cardiovascular disease including uncontrolled
hypertension, myocardial infarction or unstable angina within 6 months prior to
registration. New York Heart Association (NYHA) Grade II or greater congestive heart
failure, Serious cardiac arrhythmia requiring medication, Grade II or greater
peripheral vascular disease.
• Patients who are pregnant or nursing.
• Women of childbearing potential who are unable to use contraceptive measures during
study therapy and for at least 3 months after completion of AL3818 therapy.
• Patients with uncontrolled hypokalemia, hypomagnesaemia, and/or hypocalcaemia.
• Hemoptysis within 3 months prior to first scheduled dose of AL3818.
• Patients with acute or chronic liver disease, active hepatitis A or B with known
cirrhosis or liver dysfunction.
• Cytotoxic chemotherapy, immunotherapy, or radiotherapy within 4 weeks (6 weeks in
cases of mitomycin C, nitrosourea, lomustine) prior to first scheduled dose of AL3818
or a major surgical procedure within 28 days or minor surgical procedure performed
within 7 days prior to first scheduled dose of AL3818.
• Concomitant treatment with strong inhibitors or inducers of CYP3A4, CYP2C9 and CYP2C19
who cannot be switched to other alternative medications .
• Known history of human immunodeficiency virus infection (HIV).
• Subjects with active bacterial infections (other than uncomplicated urinary tract
infection) and/or receiving systemic antibiotics.
• Patients with other invasive malignancies, with the exception of non-melanoma skin
cancer, who had (or have) any evidence of other cancer present within the last 5 years
or whose previous cancer treatment contraindicates this protocol therapy.
• History of non-malignant GI bleeding, gastric stress ulcerations, or peptic ulcer
disease within the past 3-months that in the opinion of the investigator may place the
patient at risk of side effects on an anti-angiogenesis product.
• History of significant vascular disease (e.g. aortic aneurysm, aortic dissection).
• Intra-abdominal abscess within the last 3 months.
• Pre-existing uncontrolled hypertension as documented by 2 baseline BP readings taken
at least one hour apart, defined as systolic bloodpressure (BP) >160 mm Hg or
diastolic BP > 90 mm Hg pressure.
• QTcF>470 msec on screening ECG.
• A history of additional risk factors for TdP (e.g., heart failure, hypokalemia, family
history of Long QT Syndrome).
• The use of concomitant medications that prolong the QT/QTc interval. Baseline
echocardiogram (within 2 months) with left ventricular ejection fraction (LVEF) < 50%.
• History of difficulty swallowing, malabsorption, active partial or complete bowel
obstruction, or other chronic gastrointestinal disease or condition that may hamper
compliance and/or absorption of AL3818.
• History of pancreatitis and/or renal disease or pancreatitis that includes
histologically confirmed glomerulonephritis, biopsy proven tubulointerstitial
nephritis, crystal nephropathy, or other renal insufficiencies.
• Treatment with an investigational agent within the longest time frame of either 5
half- lives or 30 days of initiating study drug.
• Known recreational substance abuse.
• Known hypersensitivity to AL3818 or components of the formulation.
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.
• 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
To Assess Safety and Efficacy of Agents Targeting DNA Damage Repair With Olaparib Versus Olaparib Monotherapy.
This study is to assess the efficacy and safety of olaparib monotherapy versus olaparib in
combination with an inhibitor of ATR (Ataxia-Telangiectasia Mutated (ATM) and Rad3-related
protein kinase (AZD6738) and olaparib monotherapy versus olaparib in combination with an
inhibitor of WEE1 (adavosertib [AZD1775]) in second or third line setting in patients with
Triple-negative breast cancer (TNBC) prospectively stratified by presence/absence of
qualifying tumour mutation in genes involved in the homologous recombination repair (HRR)
pathway. Treatment arms are olaparib monotherapy, olaparib+AZD6738 and olaparib+adavosertib.
The study subject population will be divided into Stratum A, Stratum B, and Stratum C. Due to
the different schedules of administration of each of the treatment options as well as their
different toxicity profiles, the study is not blinded. Study has two stage consent process-
stage 1 consent (molecular screening for HRR defects) and stage 2 consent (main study).
Patients with TNBC and with known qualifying BRCAm, non BRCAm HRRm and non HRRm status will
be offered the option of consenting to the main part of the study within the 28-day screening
period. Following the ISRC meeting on 17 April 2019 a recommendation was made to close the
adavosertib+olaparib treatment arm across all biomarker strata. Patients receiving treatment
with adavosertib+olaparib treatment were offered the opportunity to continue treatment on
olaparib monotherapy at the approved dose (300 mg bd). Following the closure of this arm the
total number of patients randomised will be lower (approximately 350 patients). Approximately
300 patients will be randomised (using randomisation ratio 1:1) to 2 ongoing treatment arms
plus an additional 47 patients to a 3rd arm (olaparib+adavosertib) prior to the arm being
discontinued.
Pertinent Inclusion criteria:
1. Informed consent prior to any study specific procedures.
2. Male or female ≥18 years of age.
3. Progressive cancer at the time of study entry.
4. Histologically or cytologically confirmed TNBC at initial diagnosis with evidence of
metastatic disease and HER2 negative as per ASCO-CAP HER2 guideline recommendations
2013.
5. Patients must have received at least 1 and no more than 2 prior lines of treatment for
metastatic disease with an anthracycline (eg, doxorubicin, epirubicin) and/or a taxane
(eg, paclitaxel, docetaxel) unless contraindicated, in either the neo-adjuvant,
adjuvant or metastatic setting.
6. Confirmed presence of qualifying HRR mutation or absence of any HRR mutation in tumour
tissue by the Lynparza HRR assay.
7. At least one measurable lesion that can be accurately assessed at baseline by computed
tomography (CT) (magnetic resonance imaging [MRI] where CT is contraindicated) and is
suitable for repeated assessment as per RECIST 1.1.
8. Patients must have normal organ and bone marrow function measured within 28 days prior
to randomization (defined in the protocol).
9. ECOG PS 0-1 within 28 days of randomisation.
10. Postmenopausal or evidence of non-childbearing status for women of childbearing
potential (contraception restrictions apply to participants and their partners).
13. Patient is willing to comply with the protocol requirements. 14. Life expectancy of ≥16
weeks.
Pertinent Exclusion criteria:
1. Cytotoxic chemotherapy, hormonal or non hormonal targeted therapy within 21 days of
Cycle 1 Day 1 is not permitted. Palliative radiotherapy must have been completed 21 or
more days before Cycle 1 Day 1. The patient can receive a stable dose of
bisphosphonates or denosumab for bone metastases, before and during the study as long
as these were started at least 5 days prior to study treatment.
2. More than 2 prior lines of cytotoxic chemotherapy for metastatic disease (prior
treatments with hormonal, non-hormonal, biologics or the combination of an aromatase
inhibitor and everolimus are not counted as a prior line of therapy).
3. Previous randomisation in the present study.
4. Previous treatment with a PARP inhibitor (including olaparib) or other DDR inhibitor
(unless less than 3 weeks duration and at least 12 months has elapsed between the last
dose and randomization).
5. Exposure to a small molecule IP within 30 days or 5 half-lives (whichever is longer)
prior to randomisation. The minimum washout period for immunotherapy shall be 42 days.
6. Patients with second primary cancer (exceptions defined in the protocol).
7. Mean resting corrected QTc interval using the Fridericia formula (QTcF) >470
msec/female patients and >450 msec for male patients (as calculated per institutional
standards) or congenital long QT syndrome.
8. Any of the following cardiac diseases currently or within the last 6 months: unstable
angina pectoris, congestive heart failure ≥ Class 2 as defined by the New York Heart
Association, acute myocardial infarction, conduction abnormality not controlled with
pacemaker or medication (patients with a conduction abnormality controlled with
pacemaker or medication at the time of screening are eligible), significant
ventricular or supraventricular arrhythmias (patients with chronic rate-controlled
atrial fibrillation in the absence of other cardiac abnormalities are eligible).
9. Concomitant use of known strong or moderate cytochrome P (CYP) 3A inhibitors, strong
or moderate CYP3A inducers, or sensitive CYP3A4 substrates or CYp3A4 substrates with a
narrow therapeutic index.
10. Persistent toxicities (≥ CTCAE grade 2) caused by previous cancer therapy, excluding
alopecia and CTCAE grade 2 peripheral neuropathy.
11. Major surgery within 2 weeks of starting study treatment: patients must have recovered
from any effects of any major surgery.
12. Immunocompromised patients, eg, human immunodeficiency virus (HIV).
13. Patients with known active hepatitis (ie, hepatitis B or C).
14. Patients considered a poor medical risk due to a serious, uncontrolled medical
disorder, non malignant systemic disease or active, uncontrolled infection.
15. Patients with symptomatic uncontrolled brain metastases.
16. Patients unable to swallow orally administered medication and patients with
gastrointestinal disorders likely to interfere with absorption of the study
medication.
17. Patients with a known hypersensitivity to olaparib, adavosertib, AZD6738, or any of
the excipients of the products.
18. Pregnant or breast feeding women.
Investigation to Minimize Prolapse Recurrence of the Vagina Using Estrogen (IMPROVE)
This study randomizes postmenopausal women with symptomatic pelvic organ prolapse planning
native tissue transvaginal surgical repair to 6-8 weeks of preoperative and 1-year continued
postoperative vaginal estrogen cream compared to placebo cream. This clinical trial and basic
science investigation are designed to understand the mechanisms by which local estrogen
treatment affects connective tissues of the pelvic floor and determine whether its use before
and after prolapse repair will (i) improve success rates of the surgical intervention and
minimize prolapse recurrence and (ii) impact favorably upon symptoms of other pelvic floor
disorders.
Call 214-648-5005 studyfinder@utsouthwestern.edu
David Rahn
49553
Female
48 Years and over
Phase 4
This study is NOT accepting healthy volunteers
NCT02431897
STU 022015-117
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Inclusion Criteria:
• Postmenopausal: no menses for >1 year
• Minimum age: 48 years
• Symptomatic apical and/or anterior vaginal wall prolapse, stage 2 or greater
• No estrogen replacement within the last month (may come off current treatment, i.e.
wash out, to join the study)
• Medically fit for elective surgery
• Physically able to apply/insert the study drug
• Available for clinic follow-up for minimum 1yr
Exclusion Criteria:
• Concurrent use of steroid creams for other indications (e.g. lichen sclerosis)
• BMI >35 kg/m2
• Recent history (within last month) of vaginal infection or vaginitis
• Contraindications to estrogen therapy (e.g. spontaneous DVT, stroke, breast or
endometrial/ hormone-responsive cancer, genital bleeding of unknown cause)
• History of connective tissue disease
• Any oral or transdermal estrogen, SERM, or other medication impacting vaginal milieu
• History of vaginal irradiation
• Allergy to Premarin or its constituents
• Prior apical repair or use of mesh for prolapse repair
• Current tobacco use
Radiation Therapy With or Without Chemotherapy in Patients With Stage I-IIA Cervical Cancer Who Previously Underwent Surgery
This randomized phase III trial studies radiation therapy with chemotherapy to see how well
they work compared to radiation therapy alone in treating patients with stage I-IIA cervical
cancer who previously underwent surgery. Radiation therapy uses high-energy x-rays to kill
tumor cells. Drugs used in chemotherapy, such as cisplatin, 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. It is not yet known whether giving radiation therapy together
with chemotherapy is more effective than radiation therapy alone in treating patients with
cervical cancer.
• Pathologically proven primary cervical cancer I-IIA with squamous cell carcinoma,
adenosquamous carcinoma or adenocarcinoma initially treated with a standard radical
hysterectomy with pelvic lymphadenectomy
• Patients with the following characteristics (depth of stromal invasion and
lymphovascular space involvement to be pathologically confirmed):
• Positive capillary-lymphovascular space involvement and one of the following:
• Deep third penetration
• Middle third penetration, clinical tumor >= 2 cm
• Superficial third penetration, clinical tumor >= 5 cm
• Negative capillary-lymphatic space involvement
• Middle or deep third penetration, clinical tumor >= 4 cm
• Absolute neutrophil count (ANC) >= 1,500/mcl
• Platelets >= 100,000/mcl
• Creatinine =< upper limit of normal (ULN) or calculated creatinine clearance >= 60
mL/min
• Bilirubin =< 1.5 x normal
• Alkaline phosphate =< 3 x normal
• Serum glutamic oxaloacetic transaminase (SGOT) =< 3 x normal
• Gynecologic Oncology Group (GOG) performance status 0, 1, 2
• Patients should not be randomized less than 3 weeks post-surgery but will not be
acceptable for randomization more than 8 weeks post-surgery
• Patients who have met the pre-entry requirements
• Patients must have signed an approved informed consent and authorization permitting
release of personal health information
Exclusion Criteria:
• Patients with tumor in the parametria, pelvic lymph nodes or any other extra uterine
site or with positive surgical margins
• Patients with septicemia or severe infection
• Patients with intestinal obstruction or gastrointestinal bleeding
• Patients with postoperative fistula
• Patients with cervix cancer who have received any previous radiation or chemotherapy
• Patients whose circumstances do not permit completion of the study or the required
follow-up
• Patients with renal abnormalities requiring modification of radiation field (pelvic
kidney, renal transplant, etc.)
• Patients with GOG performance status of 3 or 4
• Patients with a history of other invasive malignancies, with the exception of
non-melanoma skin cancer, are excluded if there is any evidence of other malignancy
being present within the last five years; patients are also excluded if their previous
cancer treatment contraindicates this protocol therapy
Cervical Adenocarcinoma, Cervical Adenosquamous Carcinoma, Cervical Squamous Cell Carcinoma, Not Otherwise Specified, Stage IIA Cervical Cancer AJCC v7, Stage I Cervical Cancer AJCC v6 and v7, Stage IA Cervical Cancer AJCC v6 and v7, Stage IB Cervical Cancer AJCC v6 and v7, Cervix
Nifedipine for Acute Tocolysis of Preterm Labor (Nifedipine)
The purpose of this study is to determine if nifedipine treatment of women in preterm labor
receiving corticosteroids results in postponement of delivery when compared to placebo.
Call 214-648-5005 studyfinder@utsouthwestern.edu
Chet Wells
17851
Female
16 Years to 44 Years old
Phase 3
This study is NOT accepting healthy volunteers
NCT02132533
STU 122013-063
Show full eligibility criteria
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Inclusion Criteria:
• Between 16 and 44 years of age inclusive
• Singleton pregnancy
• Intact membranes
• Between 28-0/7 weeks and 33-6/7 weeks' gestation inclusive
• Reported or documented uterine activity
• Cervical dilation between 2 cm and 4 cm inclusive
Exclusion Criteria:
• Multifetal gestation
• Less than 28 weeks' gestation
• 34 or more weeks' gestation
• Ruptured membranes
• More than 4 cm dilated
• Previously received a course of corticosteroids for fetal lung maturation
• Oligohydramnios
• Fetal growth restriction
• Chorioamnionitis or temperature of at least 38.0 degrees Celsius
• Fetal death
• Preeclampsia
• Suspected placental abruption or placenta previa
• Lethal fetal malformation or amniotic fluid index at least 35
• Systolic BP < 90 mmHg or diastolic BP < 50 mmHg
• Baseline tachycardia (pulse >120 after 2 consecutive measurements 30 minutes apart)
• Chronic hypertension treated with antihypertensives in pregnancy
• Seizure disorder or HIV
• Maternal allergy to nifedipine
• Known maternal cardiac disease
• Women who have received progesterone therapy in the second or third trimester for
prevention of preterm birth
Drug: Nifedipine, Drug: Placebo, Other: Usual care
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.
• 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
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.
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
Study of Chemotherapy With Pembrolizumab (MK-3475) Followed by Maintenance With Olaparib (MK-7339) for the First-Line Treatment of Women With BRCA Non-mutated Advanced Epithelial Ovarian Cancer (EOC) (MK-7339-001/KEYLYNK-001/ENGOT-ov43/GOG-3036)
The purpose of this study is to assess the efficacy and safety of treatment with
carboplatin/paclitaxel* PLUS pembrolizumab (MK-3475) and maintenance olaparib (MK-7339) in
women with epithelial ovarian cancer (EOC), fallopian tube cancer, or primary peritoneal
cancer.
The primary study hypotheses are that the combination of pembrolizumab plus
carboplatin/paclitaxel* followed by continued pembrolizumab and maintenance olaparib is
superior to carboplatin/paclitaxel alone with respect to Progression Free Survival (PFS) per
Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) and/or Overall Survival
(OS), and that the combination of pembrolizumab plus carboplatin/paclitaxel followed by
continued pembrolizumab is superior to carboplatin/paclitaxel alone with respect to PFS per
RECIST 1.1 and/or OS.
• Has histologically confirmed International Federation of Gynecology and Obstetrics
(FIGO) Stage III or Stage IV EOC (high-grade predominantly serous, endometrioid,
carcinosarcoma, mixed mullerian with high-grade serous component, clear cell, or
low-grade serous OC), primary peritoneal cancer, or fallopian tube cancer
• Has just completed primary debulking surgery or is eligible for primary debulking
surgery or is a potential candidate for interval debulking surgery
• Is a candidate for carboplatin and paclitaxel chemotherapy, to be administered in the
adjuvant or neoadjuvant setting
• Candidates for neoadjuvant chemotherapy, has a cancer antigen 125 (CA-125)
(kilounits/L):carcinoembryonic antigen (CEA; ng/mL) ratio greater than or equal to 25
• Is able to provide a newly obtained core or excisional biopsy of a tumor lesion for
prospective testing of BRCA1/2 and Programmed Cell Death-Ligand 1 (PD-L1) tumor
markers status prior to randomization
• Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, as
assessed within 7 days prior to initiating chemotherapy in the lead-in period and
within 3 days prior to Day 1 of Cycle 1
• Female participants are not pregnant, not breastfeeding, and at least 1 of the
following conditions applies: a.) Not a woman of childbearing potential (WOCBP) OR b.)
Is a WOCBP and using a contraceptive method that is highly effective, with low user
dependency, or be abstinent from heterosexual intercourse as their preferred and usual
lifestyle, during the Treatment Period and for at least 180 days following the last
dose of pembrolizumab (or pembrolizumab placebo) and olaparib (or olaparib placebo)
and at least 210 days following the last dose of chemotherapy or bevacizumab (if
administered) and agrees not to donate eggs (ova, oocytes) to others or freeze/store
for personal use for the purpose of reproduction during this period. The investigator
should evaluate the potential for contraceptive method failure in relationship to the
first dose of study treatment. A WOCBP must have a negative highly sensitive pregnancy
test within either 24 hours (urine) or 72 hours (serum) before the first dose of study
treatment. If a urine test cannot be confirmed as negative, a serum pregnancy test is
required. The investigator is responsible for review of medical history, menstrual
history, and recent sexual activity to decrease the risk for inclusion of a woman with
an early undetected pregnancy. Contraceptive use by women should be consistent with
local regulations regarding the methods of contraception for those participating in
clinical studies
• Has adequate organ function
Exclusion Criteria:
• Has mucinous, germ cell, or borderline tumor of the ovary
• Has a known or suspected deleterious mutation (germline or somatic) in either BRCA1 or
BRCA2
• Has a history of non-infectious pneumonitis that required treatment with steroids or
currently has pneumonitis
• Has either myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or has features
suggestive of MDS/AML
• Has a known additional malignancy that is progressing or has required active treatment
in the last 3 years Note: Participants with basal cell carcinoma of the skin, squamous
cell carcinoma of the skin, or carcinoma in situ (e.g. ductal carcinoma in situ,
cervical carcinoma in situ) that has undergone potentially curative therapy are not
excluded.
• Has ongoing Grade 3 or Grade 4 toxicity, excluding alopecia, following chemotherapy
administered during the lead-in period
• Has known active central nervous system metastases and/or carcinomatous meningitis.
Participants with brain metastases may participate provided they were previously
treated (except with chemotherapy) and are radiologically stable, clinically stable,
and no steroids were used for the management of symptoms related to brain metastases
within 14 days prior to randomization. Stable brain metastases should be established
prior to the first dose of study medication lead-in chemotherapy
• Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy
(dosing >10 mg daily of prednisone equivalent) or any other form of immunosuppressive
therapy within 7 days prior to randomization
• Has an active autoimmune disease that has required systemic treatment in the past 2
years (i.e., with use of disease modifying agents, corticosteroids or
immunosuppressive drugs) Note: Replacement therapy (e.g. thyroxine, insulin, or
physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency)
is not considered a form of systemic treatment and is allowed.
• Has a known history of active tuberculosis (TB; Bacillus Tuberculosis)
• Has an active infection requiring systemic therapy
• Has received colony-stimulating factors (eg, granulocyte colony stimulating factor
[G-CSF], granulocyte macrophage colony-stimulating factor [GM-CSF] or recombinant
erythropoietin) within 4 weeks prior to receiving chemotherapy during the lead-in
period
• Is considered to be of poor medical risk due to a serious, uncontrolled medical
disorder, non-malignant systemic disease or active, uncontrolled infection
• Has had surgery to treat borderline tumors, early stage EOC, or early stage fallopian
tube cancer <6 months prior to screening
• Has a known history of human immunodeficiency virus (HIV) infection
• Has a known history of hepatitis B (defined as hepatitis B surface antigen [HBsAg]
reactive) or known active hepatitis C virus (defined as HCV RNA [qualitative] is
detected) infection. Testing for hepatitis B or hepatitis C is required at screening
only if mandated by local health authority. Note: Participants with a history of
hepatitis B but who are HBsAg negative are eligible for the study
• Is either unable to swallow orally administered medication or has a gastrointestinal
(GI) disorder affecting absorption (e.g. gastrectomy, partial bowel obstruction,
malabsorption)
• Has uncontrolled hypertension, defined as defined as systolic >140 mm Hg or diastolic
>90 mm Hg documented by 2 blood pressure readings taken at least 1 hour apart. Note:
This applies only to participants who will receive bevacizumab during the lead-in
period and should be confirmed prior to the first administration of bevacizumab. Use
of antihypertensive medications to control blood pressure is allowed.
• Has current, clinically relevant bowel obstruction (including sub-occlusive disease),
abdominal fistula or GI perforation, related to underlying EOC (for participants
receiving bevacizumab)
• Has a history of hemorrhage, hemoptysis or active GI bleeding within 6 months prior to
randomization (for participants receiving bevacizumab)
• Is a WOCBP who has a positive urine pregnancy test within 72 hours before the first
dose of chemotherapy in the lead-in period and within 72 hours prior to Day 1 of Cycle
1, is pregnant or breastfeeding, or is expecting to conceive children within the
projected duration of the study, starting with screening through 180 days following
the last dose of pembrolizumab (or pembrolizumab placebo) and olaparib (or olaparib
placebo) and at least 210 days following the last dose of chemotherapy or bevacizumab
(if administered)
• Has received prior treatment for any stage of OC, including radiation or systemic
anti-cancer therapy (e.g. chemotherapy, hormonal therapy, immunotherapy,
investigational therapy)
• Has received prior therapy with an anti-Programmed Cell Death-1 (anti-PD-1),
anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or
co-inhibitory T-cell receptor (e.g. cytotoxic T lymphocyte antigen-4 [CTLA-4], OX 40,
CD137)
• Has received prior therapy with either olaparib or any other poly(adenosine-ribose)
polymerase (PARP) inhibitor
• Has intraperitoneal chemotherapy planned or has been administered as first-line
therapy
• Has received a live vaccine within 30 days prior to the first dose of study treatment
on Day 1 of Cycle 1
• Has severe hypersensitivity (≥Grade 3) to pembrolizumab, olaparib, carboplatin,
paclitaxel or bevacizumab (if using) and/or any of their excipients
• Is currently receiving either strong (e.g. itraconazole, telithromycin,
clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir,
saquinavir, nelfinavir, boceprevir, telaprevir) or moderate (eg, ciprofloxacin,
erythromycin, diltiazem, fluconazole, verapamil) inhibitors of cytochrome P450
(CYP)3A4 that cannot be discontinued for the duration of the study
• Is currently receiving either strong (e.g. phenobarbital, phenytoin, rifampicin,
rifabutin, rifapentine, carbamazepine, nevirapine, and St John's Wort) or moderate
(e.g. bosentan, efavirenz, modafinil) inducers of CYP3A4 that cannot be discontinued
for the duration of the study
• Has received whole blood transfusions in the last 120 days prior to randomization
• Is currently participating or has participated in a study of an investigational agent
or has used an investigational device within 4 weeks (28 days) of starting
chemotherapy in the Lead-in Period
• Has resting electrocardiogram (ECG) indicating uncontrolled, potentially reversible
cardiac conditions or participant has congenital long QT syndrome
• Has had an allogenic tissue/solid organ transplant, has received previous allogenic
bone-marrow transplant, or has received double umbilical cord transplantation
• Either has had major surgery within 3 weeks of randomization or has not recovered from
any effects of any major surgery
Biological: Pembrolizumab, Drug: Placebo for pembrolizumab, Drug: Carboplatin, Drug: Paclitaxel, Drug: Olaparib, Drug: Placebo for olaparib, Biological: Bevacizumab, Drug: Docetaxel
A Randomized Trial of Induction Versus Expectant Management (ARRIVE)
A randomized clinical trial to assess whether elective induction of labor at 39 weeks of
gestation compared with expectant management will improve outcomes.
Call 214-648-5005 studyfinder@utsouthwestern.edu
Kenneth Leveno
14257
Female
Not specified
N/A
This study is NOT accepting healthy volunteers
NCT01990612
STU 092013-050
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Inclusion Criteria:
1. Nulliparous •no previous pregnancy beyond 20 weeks
2. Singleton gestation. Twin gestation reduced to singleton, either spontaneously or
therapeutically, is not eligible unless the reduction occurred before 14 weeks project
gestational age.
3. Gestational age at randomization between 38 weeks 0 days and 38 weeks 6 days inclusive
based on clinical information and evaluation of the earliest ultrasound.
Exclusion Criteria:
1. Project gestational age at date of first ultrasound is > 20 weeks 6 days
2. Plan for induction of labor prior to 40 weeks 5 days
3. Plan for cesarean delivery or contraindication to labor
4. Breech presentation
5. Signs of labor (regular painful contractions with cervical change)
6. Fetal demise or known major fetal anomaly
7. Heparin or low-molecular weight heparin during the current pregnancy
8. Placenta previa, accreta, vasa previa
9. Active vaginal bleeding greater than bloody show
10. Ruptured membranes
11. Cerclage in current pregnancy
12. Known oligohydramnios, defined as AFI < 5 or MVP < 2
13. Fetal growth restriction, defined as EFW < 10th percentile
14. Known HIV positivity because of modified delivery plan
15. Major maternal medical illness associated with increased risk for adverse pregnancy
outcome (for example, any diabetes mellitus, lupus, any hypertensive disorder, cardiac
disease, renal insufficiency)
16. Refusal of blood products
17. Participation in another interventional study that influences management of labor at
delivery or perinatal morbidity or mortality
18. Delivery planned elsewhere at a non-Network site
Procedure: Elective Induction of Labor
Labor and Delivery
Induction of labor, Expectant management of labor, 39 weeks gestation
A Neurosteroid Intervention for Menopausal and Perimenopausal Depression
HYPOTHESIS:
Pregnenolone administration will be associated with greater reduction in depressive symptom
severity than placebo in women with current mMDD.
STUDY AIMS:
Primary Aim: Determine if pregnenolone is associated with greater reduction in depressive
symptom severity than placebo in women with mMDD, as measured by MADRS.
Secondary Aims:
1. Determine if pregnenolone is associated with greater reduction in anxiety symptom
severity than placebo in women with mMDD.
2. Determine if pregnenolone is associated with greater improvement in cognition than
placebo in women with mMDD.
3. Determine if pregnenolone is associated with greater improvement in quality of life than
placebo in women with mMDD.
4. Determine if pregnenolone is associated with greater improvement in vasomotor symptoms
of menopause than placebo.
Mechanistic Aims:
1. Determine whether changes in neurosteroid levels with pregnenolone mediate clinical
response.
2. Determine if baseline neurosteroid levels predict pregnenolone response.
3. Determine whether depressive symptoms, anxiety, sleep or vasomotor symptoms improve
first. A crossed-lagged panel model will explore serial correlations between changes in
outcome measures.
Call 214-648-5005 studyfinder@utsouthwestern.edu
Edson Brown
10878
Female
40 Years to 67 Years old
Phase 1/Phase 2
This study is NOT accepting healthy volunteers
NCT03505905
STU 102017-068
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Inclusion Criteria:
The participants must meet the following criteria:
• Women aged 40-62 years who are perimenopausal or early postmenopausal (within 5 years
of the last menstrual period if not surgically postmenopausal), including:
• Women who have experienced changes in menstrual cycle frequency or duration, and/or
physical symptoms indicative of menopausal transition, as determined by clinician
• Women who are using hormonal IUDs (i.e. brands Mirena and Skyla), with FSH level > 20
mIU/m (as menstrual periods are irregular with IUDs that utilize hormones, making
irregular/absent periods difficult to assess as related to the menopausal transition).
• Women with significant menopause-related physical symptoms, indicated by any of the
following criteria:
• Greene Climacteric Scale total scores > 20
• Greene Climacteric Scale sub-score for vasomotor symptoms >3
• 5 or more bothersome hot flashes per week (self-reported)
• Women meeting DSM-5 criteria for current major depressive disorder (assessed by the
SCID)
• Baseline HRSD score of ≥ 18
• Subject agrees to abstain from disallowed medications for the duration of the trial
Exclusion Criteria:
The participants must not meet any of the following criteria:
• Vulnerable populations (e.g. pregnant/nursing, severe cognitive or intellectual
impairment, incarcerated)
• Pregnancy (determined by urine pregnancy test), intending pregnancy or breast feeding
• Psychiatric disorder other than MDD that is acute and the primary focus of symptom
burden or treatment.
• History of bipolar disorder or psychotic disorder
• Current substance use disorder
• Positive baseline urine drug screen of an illicit substance (in this study: opioids
and cocaine,) with the exception of a medication used with a prescription (use of a
detected substance that is used with a prescription, such as an opioid pain
medication, is not necessarily exclusionary and will be based upon judgment of the PI,
particularly in the cases of chronic opioid use). Participants who screen positive for
marijuana will be offered a rescreen for eligibility at a later date.
• Current eating disorder
• Treatment resistant depression (failure of 2 adequate antidepressant trials or
electroconvulsive therapy (ECT) during current episode; adequate antidepressant trials
are defined as within the US FDA approved dosage for the medication and used for at
least 6 weeks, with failure described by the patient as <50% improvement based on her
subjective experience).
• High risk for suicidal acts including active suicidal ideation with plan and intent or
> 2 suicide attempts in lifetime or any attempt in the past 6 months
• Use of selective estrogen-receptor modulators (SERMs), hormone replacement therapy,
hormonal contraceptives (hormonal IUDs allowed), episodic sleep medications (chronic,
regular, stable-dose benzodiazepines and hypnotics such as zolpidem, Sonata
(Zaleplon), and Lunesta (Eszopiclone) OR sleep-seating antihistamines such as Unisom
(Doxylamine succinate) or diphenhydramine allowed) within 2 weeks of the baseline
visit and randomization. Antidepressants will be allowed for those participants who
have been taking the antidepressant for 6 weeks with a stable dose for at least 4
weeks.
• Use of natural menopause and depression supplements, phytoestrogens, soy-based
medications, steroids within 2 weeks of baseline visit and randomization.
• Use of any disallowed medications (specified in the Excluded Concomitant Medication
section below).
• Women who have received a gonadal hormonal intervention within 1 month prior to study
entry (stable thyroid medications are allowed).
• Not using a medically approved method of birth control, if sexually active and not 12
or more months since last menstrual period IUDs, condoms, abstinence are acceptable
forms of contraception in this study; due to the possible interactions with the study
medication, oral contraceptive pills will be prohibited.
• Uncontrolled hypertension (>160/95mmHg)
• Active coronary artery disease, atrial fibrillation, stroke, deep vein thrombosis,
pulmonary embolism or blood clotting disorder
• Any severe, life threatening or unstable medical condition that, based on
clinician-judgment, would make participation in the study unsafe or inappropriate
• Personal or first degree family history of known hormone sensitive tumors
• History of allergic reaction or side effects with prior pregnenolone use
• Clinically significant laboratory or physical examination findings
• Concurrent enrollment in another clinical trial
Exclusion of Concomitant Medications:
• Selective estrogen-receptor modulators (SERMs)
• Hormone replacement therapy
• Hormonal contraceptives, excluding Mirena IUD or other IUD with localized progesterone
• Natural menopause or antidepressant supplements
• Episodic sleep medications (chronic, regular, stable-dose benzodiazepines and
hypnotics such as zolpidem, Sonata (Zaleplon), and Lunesta (Eszopiclone) OR
sleep-sedating antihistamines such as Unisom (Doxylamine succinate) or diphenhydramine
allowed)
• Sub-therapeutic dosages of antidepressants used for other indications will be
permissible with the exclusion of SSRIs, SNRIs, and Wellbutrin.
• Phytoestrogens
• Soy-based medications or supplements
Drug: Pregnenolone, Drug: Placebo
Major Depressive Disorder, Menopause, Perimenopause
Epidural Placement Using Handheld Ultrasound Device vs. Traditional Landmark Palpation
Ultrasound is widely in uses for vascular, nerve block and sometimes neuraxial block. The
purpose of the study is to evaluate the impact of a handheld ultrasound device on the time to
complete labor epidural placement and success rate of epidural analgesia in parturients with
a wide range of body mass indexes (BMIs).
A handheld ultrasound device (Accuro, Rhivanna Medical, Charlottesville, VA) may eliminate
the time for equipment setup due to its portability and instant power-up. In addition, it
provides a simulated diagram to aid in identifying bone and lumbar spaces. These unique
features may be helpful in laboring women with a particular BMI range. We aim to define the
usefulness of guidance with a handheld ultrasound in completing labor epidural analgesia in
various BMIs.
The primary outcome: The time needed to complete epidural placements.
Secondary outcomes:
- The number of needle insertion attempts,
- The rate of success measured by the need to replacements during the labor course for
vaginal or cesarean delivery.
Call 214-648-5005 studyfinder@utsouthwestern.edu
Michelle Eddins
138931
Female
18 Years to 50 Years old
N/A
This study is NOT accepting healthy volunteers
NCT04020042
STU-2019-0571
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Inclusion Criteria:
• Age 18-50 years
• Parturient in active labor and desires labor epidural for pain relief.
• American Society of Anesthesiologists (ASA) Class I, 2 and 3 parturients, which
include normal parturients
• Parturients with morbidities (including obesity) that are not life-threatening,
• Parturient BMI ≥ 25
Exclusion Criteria:
• History of scoliosis or back surgery
• Patient refusal
• Patient with elevated intracranial pressure
• Any patient with a contraindication for placement of epidural anesthesia, including
infection at needle insertion site, or coagulopathy.
• ASA Class 4
Testing the Addition of the Immunotherapy Drug, Pembrolizumab, to the Usual Radiation Treatment for Newly Diagnosed Early Stage High Intermediate Risk Endometrial Cancer
This phase III trial compares whether the addition of pembrolizumab to radiation therapy is
more effective than radiation therapy alone in reducing the risk of cancer coming back
(recurrence) in patients with newly diagnosed stage I-II endometrial cancer. Immunotherapy
with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack
the cancer, and may interfere with the ability of tumor cells to grow and spread. Radiation
therapy uses high energy x-rays to kill tumor cells and shrink tumors. The addition of
pembrolizumab to radiation treatment may be more effective than radiation treatment alone in
reducing cancer recurrence.
• Patients must have:
• Stage I endometrioid endometrial cancer and a combination of age and risk factors
as listed below:
• Age >= 70 and >= 1 risk factor
• Age 50 •< 70 and 2 risks factors
• Age < 50 and 3 risk factors
• Risk factors:
• Myometrial invasion >= 50%
• Lymphovascular space invasion
• Grade 2 or 3 OR
• Stage II endometrioid endometrial cancer
• Note: Patients with isolated tumor cells in sentinel lymph nodes are
eligible (considered N0i) as long as there is no evidence of micro- or
macro-metastases in any lymph nodes
• Computed tomography (CT) or magnetic resonance imaging (MRI) abdomen or pelvis and
either chest X-ray or CT chest demonstrating no evidence of disease outside of the
uterus. Imaging can be performed pre-operatively or post-operatively. CT with contrast
is the preferred modality. PET/CT is NOT to be used for any disease assessment or
reassessment unless there is documentation that PET/CT is of diagnostic quality equal
to CT with contrast
• Patients must have deficient mismatch repair as demonstrated by lack of expression of
at least one mismatch repair protein by immunohistochemistry (IHC) and/or evidence of
microsatellite instability (MSI) high. The institutional pathology report documenting
MMR deficiency must be submitted
• Patients must have undergone surgical staging with at least hysterectomy, removal of
cervix, bilateral (if both are present) salpingo-oophorectomy, and either sentinel
lymph node assessment or complete pelvic +/- aortic lymphadenectomy. Secondary staging
is allowed to determine stage. Patients with isolated tumor cells in sentinel lymph
nodes are eligible (considered N0i) as long as there is no evidence of micro- or
macro-metastases in any lymph nodes
• Patients must have received no prior therapy for endometrial cancer, including
hormonal therapy, chemotherapy, targeted therapy, immunotherapy or radiation therapy
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
• Platelets >= 100,000/mcl (within 14 days prior to registration)
• Absolute neutrophil count (ANC) >= 1,500/mcl (within 14 days prior to registration)
• Creatinine =< 1.5 x laboratory upper limit of normal (ULN) (within 14 days prior to
registration)
• Bilirubin =< 1.5 x ULN (within 14 days prior to registration) (patients with known
Gilbert's disease who have bilirubin level =< 3 x ULN may be enrolled)
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 x ULN (within
14 days prior to registration)
• Patients must be registered between 1 and 8 weeks after initial (staging) surgery
performed for the combined purpose of diagnosis and staging
• Human immunodeficiency virus (HIV) testing is not required by protocol unless
clinically indicated. Known HIV positive patients on effective anti-retroviral therapy
with undetectable viral load within 6 months are eligible for this trial
• Patients with a prior or concurrent malignancy whose natural history or treatment does
not have the potential to interfere with the safety or efficacy assessment of the
investigational regimen are eligible for this trial
• The patient or a legally authorized representative must provide study-specific
informed consent prior to study entry and, for patients treated in the United States
(U.S.), authorization permitting release of personal health information
Exclusion Criteria:
• Patients who are currently participating and receiving cancer-directed study therapy
for endometrial cancer or have participated in a study of an investigational agent and
received cancer-directed study therapy for endometrial cancer within 4 weeks prior to
registration
• Patients who have received prior treatment with anti-PD-1, anti-PD-L1, or anti-CTLA-4
therapeutic antibody or other similar agents
• Patients who have a history of a severe hypersensitivity reaction to monoclonal
antibody or MK-3475 (pembrolizumab) and/or its excipients
• Patients with active autoimmune disease or history of autoimmune disease that might
recur, which may affect vital organ function or require immune suppressive treatment
including systemic corticosteroids. This includes, but is not limited to, patients
with a history of immune related neurologic disease, multiple sclerosis, autoimmune
(demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic
autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue
diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis,
hepatitis; and patients with a history of toxic epidermal necrolysis (TEN),
Stevens-Johnson syndrome, or phospholipid syndrome because of the risk of recurrence
or exacerbation of disease. Patients with vitiligo, endocrine deficiencies including
type I diabetes mellitus, thyroiditis managed with replacement hormones including
physiologic corticosteroids are eligible. Patients with rheumatoid arthritis and other
arthropathies, Sjogren's syndrome and psoriasis controlled with topical medication and
patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid
antibodies should be evaluated for the presence of target organ involvement and
potential need for systemic treatment but should otherwise be eligible
• Patients with a history of (non-infectious) pneumonitis that required steroids, or
current pneumonitis
• Patients who have a diagnosis of immunodeficiency or are receiving systemic steroid
therapy or any other form of immunosuppressive therapy within 7 days prior to
registration:
• Patients who have received steroids as CT scan contrast premedication may be
enrolled
• The use of inhaled or topical corticosteroids is allowed
• The use of mineralocorticoids (e.g., fludrocortisone) for patients with
orthostatic hypotension or adrenocortical insufficiency is allowed
• The use of physiologic doses of corticosteroids may be approved after
consultation with the study chair (e.g. 10 mg of prednisone used for replacement
therapy for adrenal insufficiency)
• Patients who are lactating
• Known clinically significant liver disease, including active viral, alcoholic, or
other hepatitis; and cirrhosis. For patients with evidence of chronic hepatitis B
virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy,
if indicated. Patients with a history of hepatitis C virus (HCV) infection must have
been treated and cured. For patients with HCV infection who are currently on
treatment, they are eligible if they have an undetectable HCV viral load
• Uncontrolled intercurrent illness including, but not limited to: ongoing or active
infection (except for uncomplicated urinary tract infection), interstitial lung
disease or active, non-infectious pneumonitis, symptomatic congestive heart failure,
unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations
that would limit compliance with study requirements
• Patients who have received any of the prohibited medications
Endometrial Endometrioid Adenocarcinoma, Stage I Uterine Corpus Cancer AJCC v8, Stage IA Uterine Corpus Cancer AJCC v8, Stage IB Uterine Corpus Cancer AJCC v8, Stage II Uterine Corpus Cancer AJCC v8
Uterine Leiomyoma Treatment With Radiofrequency Ablation (ULTRA) Registry (ULTRA Registry)
The ULTRA Registry is a nationwide observational arm of the ULTRA trial. Data from the ULTRA
Registry will be used to evaluate the long-term safety and efficacy of laparoscopic RF
ablation (Acessa).
The ULTRA Registry will recruit women age 21 or older who plan to undergo or have undergone
laparoscopic RF ablation (Acessa) or myomectomy within the United States. Participants will
be recruited through study materials distributed at clinical offices across the country where
gynecologists are performing laparoscopic RF ablation (Acessa). Study participants will
consent to participate in a 3 year prospective study conducted by UCSF but the fibroid
procedure will be performed by the study participants' own gynecologist. We will evaluate
changes in fibroid-related symptoms from pre-treatment values to 6, 12, 18, 24, 30, and 36
months after RFA (Acessa). We will determine long-term efficacy of RFA (Acessa) by evaluating
the rate of re-treatment for symptomatic fibroids after the RFA (Acessa) procedure versus
myomectomy. Participants will be asked for permission to review their medical records to
assess surgical and pregnancy outcomes.
UC San Francisco will have oversight of all scientific and administrative aspects of the
study. All study data will be stored securely in a HIPAA compliant, secure database monitored
by the UC San Francisco Coordinating Center.
Call 214-648-5005 studyfinder@utsouthwestern.edu
Kimberly Kho
110216
Female
21 Years and over
This study is also accepting healthy volunteers
NCT02100904
STU 022018-077
Show full eligibility criteria
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Inclusion Criteria:
• Planning to undergo or have undergone* RF ablation (Acessa) or myomectomy
(laparoscopic or abdominal) for treatment of uterine fibroids.
• Able to give informed consent
• Speak English or Spanish
• Women enrolled at contracted clinical sites must enroll prior to their RF
ablation treatment
Exclusion Criteria:
• <21 years of age
• Plan to undergo hysteroscopic myomectomy
Procedure: Radiofrequency ablation of fibroids, Procedure: Myomectomy of fibroids
The Effects of Low Dose Ketamine on Cardiovascular Function
Low dose ketamine is used for pain management and for the treatment of anxiety and
depression. Prior studies on low dose ketamine have noted short-term (minutes to hours)
increases or decreases in blood pressure. Blood pressure that is too high or too low can be
problematic if untreated. It is unknown exactly how low dose ketamine affects blood pressure.
In fact, no prior studies have measured sympathetic nervous system activity after low dose
ketamine has been given to an adult. Because sympathetic nervous system activity has a large
influence on blood pressure, we need to know how exactly low dose ketamine affects these body
systems. Therefore, in this research we will study how low dose ketamine affects sympathetic
nervous system activity and cardiovascular function. The results from this research will
inform doctors about how low dose ketamine affects the sympathetic nervous system, heart, and
blood vessels.
Call 214-648-5005 studyfinder@utsouthwestern.edu
Craig Crandall
18601
All
18 Years to 45 Years old
Phase 1
This study is also accepting healthy volunteers
NCT04429685
STU-2019-1792
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Inclusion Criteria:
• Non-obese (body mass index less than 30 kg/m2)
*alternatively, individuals will be permitted to participate if they have a body mass
index value below 35 kg/m2 but a waist circumference below 88 cm for females and 102
cm for males
• Systolic blood pressure <140 mmHg
• Diastolic blood pressure <90 mmHg
Exclusion Criteria:
• Participants who have cardiac, respiratory, neurological, and/or metabolic illnesses
• Current or previous use of anti-hypertensive medications
• Any known history of renal or hepatic insufficiency/disease
• Pregnancy or breast feeding
• Current smokers, as well as individuals who regularly smoked within the past 3 years
• Individuals with a history of drug abuse
• Individuals who have an unexplained positive urine drug screen (e.g., some agents
cause false-positive results, but when the agent is abstained for hours/days/weeks,
the repeated drug screen is negative. One example could be an over-the-counter
supplement)
Semaglutide Effects on Heart Disease and Stroke in Patients With Overweight or Obesity (SELECT)
The researchers are doing the study to see if semaglutide may reduce the risk of having
cardiovascular events in patients with overweight or obesity and with prior cardiovascular
disease. The participant will either get semaglutide (active medicine) or placebo ("dummy"
medicine). Which treatment the participants get is decided by chance. The participant's
chance of getting semaglutide or placebo is the same. The participant will get the study
medicine in a pen. The participants will need to use the pen to inject the study medicine in
a skinfold once a week. The study will last for about 2.5 to 5 years. Participants will have
up to 25 clinic visits with the study doctor.
Call 214-648-5005 studyfinder@utsouthwestern.edu
Ildiko Lingvay
55880
All
45 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT03574597
STU 062018-088
Show full eligibility criteria
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Inclusion Criteria:
•Male or female, age greater than or equal to 45 years at the time of
signing informed consent •Body mass index (BMI) greater than or equal to 27 kg/m^2 •Have
established cardiovascular (CV) disease as evidenced by at least one of the following:
prior myocardial infarction; prior stroke (ischemic or haemorrhagic stroke); or symptomatic
peripheral arterial disease (PAD), as evidenced by intermittent claudication with
ankle-brachial index (ABI) less than 0.85 (at rest), or peripheral arterial
revascularization procedure, or amputation due to atherosclerotic disease Exclusion
Criteria: •Any of the following: myocardial infarction, stroke, hospitalisation for
unstable angina pectoris or transient ischaemic attack within the past 60 days prior to the
day of screening •HbA1c greater than or equal to 48 mmol/mol (6.5 %) as measured by the
central laboratory at screening •History of type 1 or type 2 diabetes (history of
gestational diabetes is allowed)
Analgesics in the Pre-hospital Setting: Implications on Hemorrhage Tolerance - Morphine
We are examining how morphine (a commonly used pain medication) will alter responses to
simulated blood loss in humans. To simulate blood loss in our research laboratory,
participants will complete a test with their lower body in a custom-designed vacuum chamber
for a brief period of time.
Call 214-648-5005 studyfinder@utsouthwestern.edu
Craig Crandall
18601
All
18 Years to 45 Years old
Phase 1/Phase 2
This study is also accepting healthy volunteers
NCT04138615
STU 092017-070
Show full eligibility criteria
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Inclusion Criteria:
• Healthy
• Non-obese (body mass index less than 30 kg/m2)
• Body mass greater than or equal to 65 kg
Exclusion Criteria:
• Subjects who have cardiac, respiratory, neurological and/or metabolic illnesses
• Any known history of renal or hepatic insufficiency/disease
• Pregnancy or breast feeding
• Current smokers, as well as individuals who regularly smoked within the past 3 years
• Positive urine drug screen
• Currently taking pain modifying medication(s)
Operations and Pelvic Muscle Training in the Management of Apical Support Loss: The OPTIMAL Trial (OPTIMAL)
Pelvic organ prolapse is common among women with a prevalence that has been estimated to be
as high as 30%. Pelvic organ prolapse often involves a combination of support defects
involving the anterior, posterior and/or apical vaginal segments. While the anterior vaginal
wall is the segment most likely to demonstrate recurrent prolapse after reconstructive
surgery, reoperations are highest among those who require apical suspension procedures with
or without repair of other vaginal segments (12%-33%). Despite the substantial health
impact, there is a paucity of high quality evidence to support different practices in the
management of prolapse, particularly surgery. Thus, the objectives of the Operations and
Pelvic Muscle Training in the Management of Apical Support Loss (OPTIMAL) Trial are:
1. to compare sacrospinous ligament fixation (SSLF) to uterosacral vaginal vault ligament
suspension (ULS); and
2. to assess the role of perioperative behavioral therapy/pelvic muscle training (PMT) in
women undergoing vaginal surgery for apical or uterine prolapse and stress urinary
incontinence.
Call 214-648-5005 studyfinder@utsouthwestern.edu
Joseph Schaffer
22212
Female
18 Years and over
Phase 3
This study is NOT accepting healthy volunteers
NCT00597935
Study00002362
Show full eligibility criteria
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Inclusion Criteria:
• Stage 2 to 4 prolapse
• Prolapse of the vaginal apex or cervix to at least half way into the vaginal canal
(POPQ Point C > -TVL/2)
• Vaginal bulge symptoms as indicated by an affirmative response to either questions on
the PFDI
• Vaginal surgery for prolapse is planned, including a vaginal apical suspension
procedure.
• Stress incontinence symptoms as indicated by an affirmative response to the PFDI
Stress incontinence subscale
• Documentation of transurethral stress leakage on an office stress test or urodynamics
with or without prolapse reduction within the previous 12 months
• A TVT is planned to treat stress urinary incontinence.
• A PMT visit can be performed at least 2 weeks and not more than 4 weeks before
surgery.
• Available for 24-months of follow-up.
• Able to complete study assessments, per clinician judgment
• Able and willing to provide written informed consent
Exclusion Criteria:
• Contraindication to SSLF, ULS, or TVT in the opinion of the treating surgeon.
• History of previous surgery that included a SSLF or ULS. (Previous vaginal vault
suspensions using other techniques or in which the previous technique is unknown are
eligible.)
• Pelvic pain or dyspareunia due to levator ani spasm that would preclude a PMT
program.
• History of previous synthetic sling procedure for stress incontinence.
• Previous adverse reaction to synthetic mesh.
• Urethral diverticulum, current or previous (i.e., repaired)
• History of femoral to femoral bypass.
• Current cytotoxic chemotherapy or current or history of pelvic radiation therapy.
• History of two inpatient hospitalizations for medical comorbidities in the previous
12 months.
• Subject wishes to retain her uterus. [Both ULS and SLS include removal of the uterus,
if not previously removed]
A Study of a Levonorgestrel-Releasing Intrauterine System for Long-Term, Reversible Contraception
The primary objective of this study is to assess the efficacy of a levonorgestrel-releasing
intrauterine system (LNG20) in nulliparous and parous females of child-bearing potential who
request long-term, reversible contraception for up to 10 years.
Call 214-648-5005 studyfinder@utsouthwestern.edu
Denisse Holcomb
81275
Female
16 Years to 45 Years old
Phase 3
This study is also accepting healthy volunteers
NCT00995150
STU 062010-087
Show full eligibility criteria
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Inclusion Criteria:
• Healthy women requesting contraception
• 16-35 years old
• Cohort 36-45 years old
• Sexually active
Exclusion Criteria:
• Currently pregnant, pregnant within 4 weeks prior to study entry or planning pregnancy
within 24 months of study entry
• Currently breastfeeding
• Current persistent, abnormal vaginal bleeding