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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)

Last updated on April 18, 2019

FOR MORE INFORMATION
Study Location
Marin Cancer Care, Inc.
Greenbrae, California, 94904 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Neoplasms, BRCA 1 Gene Mutation, BRCA 2 Gene Mutation
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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

NCT02034916
Pfizer
Completed
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)

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Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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