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 August 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: August 21, 2014
Last verified: August 2014
  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.


Condition Intervention Phase
Breast Neoplasms
BRCA 1 Gene Mutation
BRCA 2 Gene Mutation
Drug: talazoparib
Drug: Physician's-Choice
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by BioMarin Pharmaceutical:

Primary Outcome Measures:
  • Progression Free Survival (PFS) [ Time Frame: Anticipated in about 24-30 months following first patient enrolled ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Other Outcome Measures:
  • 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


Estimated Enrollment: 429
Study Start Date: October 2013
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: talazoparib
Patient will be randomized 2:1 to receive talazoparib oral capsules (1.0 mg) once daily for 21 continuous days
Drug: talazoparib
Until progression or unacceptable toxicity develops
Active Comparator: Physician's-Choice
Capecitabine, Eribulin, Gemcitabine or Vinorelbine
Drug: Physician's-Choice
Capecitabine, Eribulin, Gemcitabine or Vinorelbine

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01945775

Contacts
Contact: Ashley Powne Ashley.Powne@bmrn.com

  Show 73 Study Locations
Sponsors and Collaborators
BioMarin Pharmaceutical
National Breast Cancer Coalition (NBCC)
Translational Research in Oncology
US Oncology Research
Myriad Genetics, Inc.
  More Information

No publications provided

Responsible Party: BioMarin Pharmaceutical
ClinicalTrials.gov Identifier: NCT01945775     History of Changes
Other Study ID Numbers: 673-301, U1111-1155-7579
Study First Received: September 11, 2013
Last Updated: August 21, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by BioMarin Pharmaceutical:
Breast cancer
BRCA mutation
PARP inhibitor
BRCA 1
BRCA 2

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 18, 2014