Talazoparib For Neoadjuvant Treatment Of Germline Brca1/2 Mutation Patients With Early Triple-negative Breast Cancer
Status: | Recruiting |
---|---|
Conditions: | Breast Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/17/2019 |
Start Date: | August 27, 2018 |
End Date: | December 1, 2023 |
Contact: | Pfizer CT.gov Call Center |
Email: | ClinicalTrials.gov_Inquiries@pfizer.com |
Phone: | 1-800-718-1021 |
A PHASE 2, NON-RANDOMIZED, OPEN LABEL, SINGLE ARM, MULTI-CENTER STUDY OF TALAZOPARIB FOR NEOADJUVANT TREATMENT OF GERMLINE BRCA1/2 MUTATION PATIENTS WITH EARLY TRIPLE-NEGATIVE BREAST CANCER
A PHASE 2, NON RANDOMIZED, OPEN LABEL, SINGLE ARM, MULTI CENTER STUDY OF TALAZOPARIB FOR
NEOADJUVANT TREATMENT OF GERMLINE BRCA1/2 MUTATION PATIENTS WITH EARLY TRIPLE NEGATIVE BREAST
CANCER
NEOADJUVANT TREATMENT OF GERMLINE BRCA1/2 MUTATION PATIENTS WITH EARLY TRIPLE NEGATIVE BREAST
CANCER
TALAZOPARIB (PARP INHIBITOR) FOR NEOADJUVANT TREATMENT OF GERMLINE BRCA1/2 MUTATION PATIENTS
WITH EARLY TRIPLE NEGATIVE BREAST CANCER. THIS IS A MONOTHERAPY TREATMENT FOR 24 WKS FOLLOWED
BY SURGERY TO EVALUATE PATHOLOGICAL COMPLETE RESPONSE.
WITH EARLY TRIPLE NEGATIVE BREAST CANCER. THIS IS A MONOTHERAPY TREATMENT FOR 24 WKS FOLLOWED
BY SURGERY TO EVALUATE PATHOLOGICAL COMPLETE RESPONSE.
Inclusion Criteria:
- Germline BRCA 1/2 Mutation Positive
- Women and men at least 18 years of age or older.
- Histologically confirmed invasive triple negative Breast Cancer
- Tumor greater than or equal toT1
- No evidence of distant metastasis
- Adequate bone marrow, hepatic, and renal function
- ECOG performance status 0 or 1
Exclusion Criteria:
- Any other previous antitumor therapies for the current cancer event. Treatment for
ductal carcinoma in situ (DCIS) is allowed; ie, surgery, hormonal therapy and
radiation.
- Evidence of distant metastasis apparent prior to randomization
- Patients with inflammatory breast carcinoma
- Malignancy within the last 3 years, except:: Adequately treated non melanoma skin
cancer; Curatively treated in situ cancer of the cervix; Stage 1, Grade 1 endometrial
carcinoma; or Adequately treated contralateral breast carcinoma which has been disease
free for a year; Other solid tumors including lymphomas (without bone marrow
involvement) curatively treated with no evidence of disease for 5 years.
- Previous or concomitant systemic anti cancer therapies used for the treatment of
cancer in the last 3 years.
- Prior treatment with a PARP inhibitor in any disease setting
- Concomitant use of Strong P gp inhibitors or inducers or BCRP inhibitors
- Patients who are unwilling or unable to use 2 highly effective methods of
contraception as outlined in this protocol
- Major surgery within 14 days prior to study entry
- Known history of cardiac disease, for example : Myocardial infarction or symptomatic
cardiac ischemia within 24 weeks before screening; Congestive heart failure New York
Heart Association Class III or IV; History of clinically significant ventricular
arrhythmias within one year prior to randomization; History of Mobitz II second degree
or third degree heart block, uncontrolled hypertension.
- Active clinically significant infection
- Clinically significant bleeding diathesis or coagulopathy
- Non healing wound, ulcer or bone fracture
- Known hypersensitivity to any of the components of talazoparib
- Patients with myelodysplastic syndrome/acute myeloid leukemia
- Patients with uncontrolled seizures.
- Any evidence of other disease or any concomitant medical or psychiatric problems which
in the opinion of the Investigator would prevent completion of treatment
We found this trial at
120
sites
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University of Mississippi Medical Center The University of Mississippi Medical Center, located in Jackson, is...
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Avera Cancer Institute Avera, the health ministry of the Benedictine and Presentation Sisters, is a...
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Emory University Hospital Midtown Emory University Hospital Midtown is a 511-bed community-based, acute care teaching...
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Emory University Hospital As the largest health care system in Georgia and the only health...
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Camarillo, California 93010
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Chicago, Illinois 60612
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1500 East Duarte Road
Duarte, California 91010
Duarte, California 91010
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1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Virginia Oncology Associates Virginia Oncology Associates is an oncology and hematology practice of physicians, specializing...
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Oxnard, California 93030
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300 Halket St.
Pittsburgh, Pennsylvania 15213
Pittsburgh, Pennsylvania 15213
1-866-MyMagee (696-2433)
Magee-Womens Hospital of UPMC Magee-Womens Hospital of UPMC is a world-class center for both women's...
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