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

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.

Stanford is currently not accepting patients for this trial.

Stanford Investigator(s):

Intervention(s):

  • drug: talazoparib
  • drug: Physician's-Choice

Eligibility


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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting

Our research team includes physicians, residents, medical students, research assistants, and volunteers. Our research topics include medical imaging, device validation,  mobile application development, and pharmaceutical trials.  

Some of the Neuro-Opthalmic concerns we investigate include Multiple Sclerosis, Optic Neuritis, IIH, and ICP.