A Study Evaluating Talazoparib (BMN 673), a PARP Inhibitor, in Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (EMBRACA Study)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by BioMarin Pharmaceutical
Sponsor:
Collaborators:
National Breast Cancer Coalition (NBCC)
Translational Research in Oncology
US Oncology Research
Myriad Genetics, Inc.
Information provided by (Responsible Party):
BioMarin Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01945775
First received: September 11, 2013
Last updated: September 29, 2014
Last verified: September 2014

September 11, 2013
September 29, 2014
October 2013
June 2016   (final data collection date for primary outcome measure)
Progression Free Survival (PFS) [ Time Frame: Anticipated in about 24-30 months following first patient enrolled ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01945775 on ClinicalTrials.gov Archive Site
  • Evaluate objective response rate (ORR) [ Time Frame: Anticipated in about 24-30 months following first patient enrolled ] [ Designated as safety issue: No ]
  • Evaluate overall survival (OS) [ Time Frame: Anticipated in about 24-30 months following first patient enrolled ] [ Designated as safety issue: No ]
Same as current
  • Duration of response (DOR) for objective responders [ Time Frame: Anticipated in about 24-30 months following first patient enrolled ] [ Designated as safety issue: No ]
  • Health-related quality of life [ Time Frame: Anticipated in about 24-30 months following first patient enrolled ] [ Designated as safety issue: No ]
    2 Validated questionnaires to assess general quality of life and deterioration due to breast cancer
Same as current
 
A Study Evaluating Talazoparib (BMN 673), a PARP Inhibitor, in Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (EMBRACA Study)
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Breast Neoplasms
  • BRCA 1 Gene Mutation
  • BRCA 2 Gene Mutation
  • Drug: talazoparib
    Until progression or unacceptable toxicity develops
  • Drug: Physician's-Choice
    Capecitabine, Eribulin, Gemcitabine or Vinorelbine
  • Experimental: talazoparib
    Patient will be randomized 2:1 to receive talazoparib oral capsules (1.0 mg) once daily for 21 continuous days
    Intervention: Drug: talazoparib
  • Active Comparator: Physician's-Choice
    Capecitabine, Eribulin, Gemcitabine or Vinorelbine
    Intervention: Drug: Physician's-Choice
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
429
Not Provided
June 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Katie MacQuien katie.macquien@bmrn.com
United States,   Australia,   Belgium,   France,   Germany,   Ireland,   Italy,   Korea, Republic of,   Poland,   Russian Federation,   Spain,   Taiwan,   United Kingdom
 
NCT01945775
673-301, U1111-1155-7579
No
BioMarin Pharmaceutical
BioMarin Pharmaceutical
  • National Breast Cancer Coalition (NBCC)
  • Translational Research in Oncology
  • US Oncology Research
  • Myriad Genetics, Inc.
Not Provided
BioMarin Pharmaceutical
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP