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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)

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NCT02034916

Last updated on November 14, 2019
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FOR MORE INFORMATION
Study Location
Marin Cancer Care, Inc.
Greenbrae, California, 94904 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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
Terminated
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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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:

  • 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
Detailed DescriptionNot 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
  • Breast Neoplasms
  • BRCA 1 Gene Mutation
  • BRCA 2 Gene Mutation
Intervention  ICMJE Drug: talazoparib
Other Names:
  • MDV3800
  • BMN673
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 *Not Provided


*   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
 (submitted: November 19, 2018)		84
Original Estimated Enrollment  ICMJE
 (submitted: January 10, 2014)		140
Actual Study Completion Date  ICMJE October 31, 2018
Actual Primary Completion DateSeptember 1, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
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 CommitteeNot Provided
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da....
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da...
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE
  • Myriad Genetic Laboratories, Inc.
  • Medivation, Inc.
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateOctober 2019

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

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1-800-718-1021

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