Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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) (ABRAZO)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Myriad Genetic Laboratories, Inc.
Information provided by (Responsible Party):
Medivation, Inc.
ClinicalTrials.gov Identifier:
NCT02034916
First received: January 9, 2014
Last updated: July 13, 2016
Last verified: May 2016

January 9, 2014
July 13, 2016
January 2014
December 2016   (final data collection date for primary outcome measure)
Determine Objective Response Rate (ORR) for each cohort [ Time Frame: Anticipated in about 24-30 months following first patient enrolled ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT02034916 on ClinicalTrials.gov Archive Site
  • Clinical benefit response (CBR) rate defined as CR + PR + SD lasting ≥ 24 weeks [ Time Frame: Anticipated in about 24-30 months following first patient enrolled ] [ Designated as safety issue: No ]
  • Duration of response (DOR) for objective responders [ Time Frame: Anticipated in about 24-30 months following first patient enrolled ] [ Designated as safety issue: No ]
  • Progression Free Survival (PFS) [ Time Frame: Anticipated in about 24-30 months following first patient enrolled ] [ Designated as safety issue: No ]
  • Overall survival (OS) [ Time Frame: Anticipated in about 24-30 months following first patient enrolled ] [ Designated as safety issue: No ]
  • Safety as assessed by percentage of patients with any Adverse Event (AE), AE leading to Study Drug Discontinuation, AE leading to death, SAE, AE related to study drug, SAE related to study drug. [ Time Frame: Anticipated in about 24-30 months following first patient enrolled ] [ Designated as safety issue: No ]
  • Pharmacokinetics of talazoparib as assessed by trough plasma concentrations collected on Day 1 of Cycles 2, 3, and 4 [ Time Frame: Anticipated in about 24-30 months following first patient enrolled ] [ Designated as safety issue: No ]
  • Clinical benefit response (CBR) rate defined as CR + PR + SD lasting ≥ 24 weeks [ Time Frame: Anticipated in about 24-30 months following first patient enrolled ] [ Designated as safety issue: No ]
  • Duration of response (DOR) for objective responders [ Time Frame: Anticipated in about 24-30 months following first patient enrolled ] [ Designated as safety issue: No ]
  • Progression Free Survival (PFS) [ Time Frame: Anticipated in about 24-30 months following first patient enrolled ] [ Designated as safety issue: No ]
  • Overall survival (OS) [ Time Frame: Anticipated in about 24-30 months following first patient enrolled ] [ Designated as safety issue: No ]
Health-related quality of life [ Time Frame: Anticipated in about 24-30 months following first patient enrolled ] [ Designated as safety issue: No ]
Same as current
 
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)
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

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
Not Provided
Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Breast Neoplasms
  • BRCA 1 Gene Mutation
  • BRCA 2 Gene Mutation
Drug: talazoparib
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
140
Not Provided
December 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   France,   Germany,   Spain,   United Kingdom
 
NCT02034916
673-201
Not Provided
Not Provided
Not Provided
Medivation, Inc.
Medivation, Inc.
Myriad Genetic Laboratories, Inc.
Not Provided
Medivation, Inc.
May 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP