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A Study Evaluating Talazoparib (BMN 673), a PARP Inhibitor, in Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (EMBRACA Study)
Overall Recruitment Status: Active, enrollment completed
 
Official Title
A Phase 3, Open-Label, Randomized, Parallel, 2-Arm, Multi-Center Study of BMN 673 Versus Physician's Choice in Germline BRCA Mutation Subjects With Locally Advanced and/or Metastatic Breast Cancer, Who Have Received No More Than 2 Prior Chemotherapy Regimens for Metastatic Disease
 
Region Sponsors
California - Northern
Medivation, Inc.
 
Acronym KP IRB No.
EMBRACA CN-14-1878-B
 
Study Type Phase
Clinical Trial Phase III
 
Study Population Description
Individuals with Breast Neoplasms, BCRA 1 Gene Mutation, BRCA 2 Mutation
 
Purpose
The purpose of this open-label, 2:1 randomized phase III trial is to compare the safety and efficacy of talazoparib (also known as BMN 673) versus protocol-specific physician's choice in patients who have locally advanced and/or metastatic breast cancer with germline BRCA mutations.
 
Detailed Description
 
Gender Age Limit
Male & Female
 
Inclusion Criteria
  • Histologically or cytologically confirmed carcinoma of the breast
  • Locally advanced and/or metastatic disease appropriate for systemic single cytotoxic chemotherapy
  • Deleterious or pathogenic germline BRCA1 or BRCA2 mutation No more than 2 prior chemotherapy-inclusive regimens for locally advanced and/or metastatic disease
  • Prior treatment with a taxane and/or anthracycline in the adjuvant or metastatic setting
  • ECOG performance status <= 1
  • Have adequate organ function
 
Exclusion Criteria
  • Prior treatment with a PARP inhibitor
  • Prior platinum treatment for metastatic disease. Subjects who have received platinum in the adjuvant or neoadjuvant setting are eligible
  • 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

 
Keywords and/or Specific Medical Conditions
  • BRCA 1
  • Neoplasms
  • BRCA 2
  • Neoplasms by Site
  • BRCA mutation
  • PARP inhibitor
  • Breast cancer
  • Skin Diseases
  • Breast Diseases
  • Oncology (Adult)
  • Breast Neoplasms
 
KP Clinical Facility
  • Diablo Medical Center-Walnut Creek
  • Hayward Medical Center
  • Oakland Medical Center
  • Roseville Medical Center
  • Sacramento Medical Center
  • San Francisco Medical Center
  • Santa Teresa Medical Center-San Jose
  • South San Francisco Medical Center
  • Vallejo Medical Center
 
Clinical Area
  • Oncology (Adult)


Principal Investigator:
Jennifer Suga, MD
Contact Information:
- Desiree Goldstein, RN
-desiree.goldstein@kp.org
-Vallejo Medical Center


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