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)
NCT02034916
Last updated date
ABOUT THIS STUDY
The purpose of this 2-stage, 2-cohort Phase 2 trial is to evaluate the safety and efficacy of
talazoparib (also known as BMN 673) in subjects 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 with a documented PR or CR to a prior platinum-containing regimen for
metastatic disease with disease progression > 8 weeks following the last dose of
platinum; or
- Cohort 2) Subjects who have received > 2 prior chemotherapy regimens for metastatic
disease and who have had no prior platinum therapy for metastatic disease
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
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
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
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ALL GENDERS
18 Years+
years
MULTIPLE SITES
Breast Neoplasms, BRCA 1 Gene Mutation, BRCA 2 Gene MutationA 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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- Sutton,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
| Descriptive Information | |||||||
|---|---|---|---|---|---|---|---|
| Brief Title ICMJE | 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) | ||||||
| Official Title ICMJE | A PHASE 2, 2-STAGE, 2-COHORT STUDY OF TALAZOPARIB (BMN 673) ADMINISTERED TO GERMLINE BRCA MUTATION SUBJECTS WITH LOCALLY ADVANCED AND/OR METASTATIC BREAST CANCER | ||||||
| Brief Summary | The purpose of this 2-stage, 2-cohort Phase 2 trial is to evaluate the safety and efficacy of talazoparib (also known as BMN 673) in subjects 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:
| ||||||
| Detailed Description | Not Provided | ||||||
| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Phase 2 | ||||||
| Study Design ICMJE | Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | ||||||
| Condition ICMJE |
| ||||||
| Intervention ICMJE | Drug: talazoparib
Other Names:
| ||||||
| Study Arms ICMJE | Experimental: talazoparib
Cohort 1) Subjects with a documented PR or CR to a prior platinum-containing regimen for metastatic disease with disease progression > 8 weeks following the last dose of platinum Cohort 2) Subjects who have received > 2 prior chemotherapy regimens for metastatic disease and who have had no prior platinum therapy for metastatic disease Intervention: Drug: talazoparib | ||||||
| Publications * | Turner NC, Telli ML, Rugo HS, Mailliez A, Ettl J, Grischke EM, Mina LA, Balmaña J, Fasching PA, Hurvitz SA, Wardley AM, Chappey C, Hannah AL, Robson ME; ABRAZO Study Group. A Phase II Study of Talazoparib after Platinum or Cytotoxic Nonplatinum Regimens in Patients with Advanced Breast Cancer and Germline BRCA1/2 Mutations (ABRAZO). Clin Cancer Res. 2019 May 1;25(9):2717-2724. doi: 10.1158/1078-0432.CCR-18-1891. Epub 2018 Dec 18. | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
| Recruitment Information | |||||||
| Recruitment Status ICMJE | Terminated | ||||||
| Actual Enrollment ICMJE | 84 | ||||||
| Original Estimated Enrollment ICMJE | 140 | ||||||
| Actual Study Completion Date ICMJE | October 31, 2018 | ||||||
| Actual Primary Completion Date | September 1, 2016 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| ||||||
| Sex/Gender ICMJE |
| ||||||
| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries ICMJE | France, Germany, Spain, United Kingdom, United States | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT02034916 | ||||||
| Other Study ID Numbers ICMJE | 673-201 2013-003076-12 ( EudraCT Number ) C3441008 ( Other Identifier: Alias Study Number ) | ||||||
| Has Data Monitoring Committee | Not Provided | ||||||
| U.S. FDA-regulated Product | Not Provided | ||||||
| IPD Sharing Statement ICMJE |
| ||||||
| Responsible Party | Pfizer | ||||||
| Study Sponsor ICMJE | Pfizer | ||||||
| Collaborators ICMJE |
| ||||||
| Investigators ICMJE |
| ||||||
| PRS Account | Pfizer | ||||||
| Verification Date | October 2019 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||||