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A Phase 2, 2-Stage, 2-Cohort Study of Talazoparib (BMN 673), in Locally Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (ABRAZO Study)
Not Recruiting
Trial ID: NCT02034916
Purpose
The purpose of this 2-stage, 2-cohort Phase 2 trial is to evaluate the safety and efficacy of
talazoparib (also known as BMN 673) in subjects with locally advanced or metastatic breast
cancer with a deleterious germline BRCA 1 or BRCA 2 mutation. Subjects will be assigned to
either Cohort 1 or 2 based on prior chemotherapy for metastatic disease:
- Cohort 1) Subjects with a documented PR or CR to a prior platinum-containing regimen for
metastatic disease with disease progression > 8 weeks following the last dose of
platinum; or
- Cohort 2) Subjects who have received > 2 prior chemotherapy regimens for metastatic
disease and who have had no prior platinum therapy for metastatic disease
Official Title
A PHASE 2, 2-STAGE, 2-COHORT STUDY OF TALAZOPARIB (BMN 673) ADMINISTERED TO GERMLINE BRCA MUTATION SUBJECTS WITH LOCALLY ADVANCED AND/OR METASTATIC BREAST CANCER
Stanford Investigator(s)
Melinda L. Telli, M.D.
Professor of Medicine (Oncology)
Allison W. Kurian, M.D., M.Sc.
Professor of Medicine (Oncology) and of Epidemiology and Population Health
Eligibility
Inclusion Criteria:
- Histologically or cytologically confirmed carcinoma of the breast
- Locally advanced and/or metastatic disease
- Deleterious or pathogenic germline BRCA 1 or BRCA 2 mutation
- Prior chemotherapy: Cohort 1) PR or CR to prior platinum-containing regimen for
metastatic disease with disease progression > 8 weeks following the last dose of
platinum; or Cohort 2) > 2 prior chemotherapy regimens for metastatic disease and no
prior platinum for metastatic disease
- ECOG performance status ≤ 1
- Have adequate organ function
Exclusion Criteria:
- Prior enrollment into a clinical trial of a PARP inhibitor
- CNS metastasis except adequately treated brain metastasis documented by baseline CT or
MRI scan that has not progressed since previous scans and that does not require
corticosteroids for management of CNS symptoms
- Prior malignancy except for prior BRCA-associated cancer as long as there is no
current evidence of the prior cancer, carcinoma in situ of the cervix or non-melanoma
skin cancer, and a cancer diagnosed and definitively treated >5 years prior to study
enrollment with no subsequent evidence of recurrence
- Known to be HIV positive, active hepatitis C virus, or active hepatitis B virus
- Known hypersensitivity to any of the components of talazoparib
Intervention(s):
drug: talazoparib
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-498-7061