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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) (EMBRACA)

This study is ongoing, but not recruiting participants.
Medivation is now a wholly owned subdiary of Pfizer, Inc.
Information provided by (Responsible Party):
Pfizer Identifier:
First received: September 11, 2013
Last updated: September 8, 2017
Last verified: September 2017
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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Open-label, Randomized Parallel,2-arm,Multi-center Study Of Talazoparib(Bmn 673) Versus Physician's Choice In Germline Brca Mutation Subjects With Locally Advanced And/or Metastatic Breast Cancer, Who Have Received Prior Chemotherapy Regimens For Metastatic Disease

Resource links provided by NLM:

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Progression Free Survival (PFS) [ Time Frame: Anticipated in about 41 months following first patient enrolled ]

Secondary Outcome Measures:
  • Evaluate objective response rate (ORR) [ Time Frame: Anticipated in about 41 months following first patient enrolled ]
  • Evaluate overall survival (OS) [ Time Frame: Anticipated in about 41 months following first patient enrolled ]
  • Safety as assessed by percentage of patients with any Adverse Event (AE) [ Time Frame: Anticipated in about 41 months following first patient enrolled ]
  • Pharmacokinetics of talazoparib as assessed by trough plasma concentrations [ Time Frame: Anticipated in about 41 months following first patient enrolled ]

Other Outcome Measures:
  • Duration of response (DOR) for objective responders [ Time Frame: Anticipated in about 41 months following first patient enrolled ]
  • Health-related quality of life [ Time Frame: Anticipated in about 41 months following first patient enrolled ]
    2 Validated questionnaires to assess general quality of life and deterioration due to breast cancer

Enrollment: 442
Actual Study Start Date: October 14, 2013
Estimated Study Completion Date: December 27, 2019
Estimated Primary Completion Date: September 15, 2017 (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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically or cytologically confirmed carcinoma of the breast
  • Locally advanced breast cancer that is not amenable to curative radiation or surgical cure and/or metastatic disease appropriate for systemic single cytotoxic chemotherapy
  • Documentation of a deleterious, suspected deleterious, or pathogenic germline BRCA1 or BRCA2 mutation from Myriad Genetics or other laboratory approved by the Sponsor
  • No more than 3 prior chemotherapy-inclusive regimens for locally advanced and/or metastatic disease (no limit on prior hormonal therapies or targeted anticancer therapies such as mechanistic target of rapamycin (mTOR) or CDK4/6 inhibitors, immune-oncology agents, tyrosine kinase inhibitors, or monoclonal antibodies against CTL4 or VEGF)
  • Prior treatment with a taxane and/or anthracycline in the neoadjuvant, adjuvant, locally advanced, or metastatic setting unless medically contraindicated
  • Have measurable or non-measurable, evaluable disease by the revised response evaluation criteria in solid tumors (RECIST) v.1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

Exclusion Criteria:

  • First-line locally advanced and/or metastatic breast cancer with no prior adjuvant chemotherapy unless the Investigator determines that one of the 4 cytotoxic chemotherapy agents in the control arm would otherwise be offered to the subject
  • Prior treatment with a PARP inhibitor (not including iniparib)
  • Not a candidate for treatment with at least 1 of the treatments of protocol-specific physician's choice (ie, capecitabine, eribulin, gemcitabine, vinorelbine)
  • Subjects who had objective disease progression while receiving platinum chemotherapy administered for locally advanced or metastatic disease; subjects who received low-dose platinum therapy administered in combination with radiation therapy are not excluded
  • Subjects who have received platinum in the adjuvant or neoadjuvant setting are eligible; however, subjects may not have relapsed within 6 months of the last dose of prior platinum therapy
  • Cytotoxic chemotherapy within 14 days before randomization
  • Radiation or anti-hormonal therapy or other targeted anticancer therapy within 14 days before randomization
  • HER2 positive breast cancer
  • Active inflammatory breast cancer
  • CNS metastases

    • Exception: Adequately treated brain metastases documented by baseline CT or MRI scan that has not progressed since previous scans and that does not require corticosteroids (except prednisone ≤ 5 mg/day or equivalent) for management of CNS symptoms. A repeat CT or MRI following the identification of CNS metastases (obtained at least 2 weeks after definitive therapy) must document adequately treated brain metastases.
    • Subjects with leptomeningeal carcinomatosis are not permitted
  • Prior malignancy except for any of the following:

    • Prior BRCA-associated cancer as long as there is no current evidence of the cancer
    • Carcinoma in situ or non-melanoma skin cancer
    • A cancer diagnosed and definitively treated ≥ 5 years before randomization with no subsequent evidence of recurrence
  • Known to be human immunodeficiency virus positive
  • Known active hepatitis C virus, or known 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 identifier: NCT01945775

  Show 442 Study Locations
Sponsors and Collaborators
Medivation is now a wholly owned subdiary of Pfizer, Inc.
Study Director: Pfizer Pfizer Call Center Pfizer
  More Information

Responsible Party: Pfizer Identifier: NCT01945775     History of Changes
Other Study ID Numbers: 673-301
C3441009 ( Other Identifier: Alias Study Number )
2013-002716-28 ( EudraCT Number )
U1111-1155-7579 ( Other Identifier: Universal Trial Number )
Study First Received: September 11, 2013
Last Updated: September 8, 2017

Keywords provided by Pfizer:
Breast cancer
BRCA mutation
PARP inhibitor

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents processed this record on September 21, 2017