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
  Purpose

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

Condition Intervention Phase
Breast Neoplasms
BRCA 1 Gene Mutation
BRCA 2 Gene Mutation
Drug: talazoparib
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Medivation, Inc.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Other Outcome Measures:
  • Health-related quality of life [ Time Frame: Anticipated in about 24-30 months following first patient enrolled ] [ Designated as safety issue: No ]

Enrollment: 140
Study Start Date: January 2014
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Drug: talazoparib

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02034916

  Show 41 Study Locations
Sponsors and Collaborators
Medivation, Inc.
Myriad Genetic Laboratories, Inc.
  More Information

Responsible Party: Medivation, Inc.
ClinicalTrials.gov Identifier: NCT02034916     History of Changes
Other Study ID Numbers: 673-201 
Study First Received: January 9, 2014
Last Updated: July 13, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Medivation, Inc.:
Breast cancer
BRCA mutation
PARP inhibitor
BRCA 1
BRCA 2

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Talazoparib
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on August 23, 2016