Trial Search Results

A Phase 2, 2-Stage, 2-Cohort Study of Talazoparib (BMN 673), in Locally Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (ABRAZO Study)

The purpose of this trial is to study talazoparib (also known as BMN 673) in patients with locally advanced or metastatic breast cancer with a deleterious germline BRCA 1 or BRCA 2 mutation. Subjects will be assigned to either Cohort 1 or 2 based on prior chemotherapy for metastatic disease:

Cohort 1) Subjects who have previously responded to platinum-containing regimen for metastatic disease with disease progression > 8 weeks following the last dose of platinum; orCohort 2) Subjects who have received > 2 chemotherapy regimens and who have had no prior platinum therapy for metastatic disease

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Pfizer

Collaborator: Medivation, Inc.

Intervention(s):

  • Drug: talazoparib

Phase:

Phase 2

Eligibility


Inclusion Criteria:

   - Histologically or cytologically confirmed carcinoma of the breast

   - Locally advanced and/or metastatic disease

   - Deleterious or pathogenic germline BRCA 1 or BRCA 2 mutation

   - Prior chemotherapy: Cohort 1) PR or CR to prior platinum-containing regimen for
   metastatic disease with disease progression > 8 weeks following the last dose of
   platinum; or Cohort 2) > 2 prior chemotherapy regimens for metastatic disease and no
   prior platinum for metastatic disease

   - ECOG performance status ≤ 1

   - Have adequate organ function

Exclusion Criteria:

   - Prior enrollment into a clinical trial of a PARP inhibitor

   - 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

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