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)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by BioMarin Pharmaceutical
Sponsor:
Collaborators:
Translational Research in Oncology
Myriad Genetics, Inc.
Information provided by (Responsible Party):
BioMarin Pharmaceutical
ClinicalTrials.gov Identifier:
NCT02034916
First received: January 9, 2014
Last updated: September 29, 2014
Last verified: September 2014
  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 who have previously responded to 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 chemotherapy regimens 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 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 BioMarin Pharmaceutical:

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 ]

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 ]

Estimated Enrollment: 140
Study Start Date: January 2014
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: talazoparib

Cohort 1) Subjects who have previously responded to a 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 and who have had no prior platinum therapy for metastatic disease

Drug: talazoparib

  Eligibility

Ages Eligible for Study:   18 Years and older
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

Contacts
Contact: Katie MacQuien katie.macquien@bmrn.com

Locations
United States, Arizona
Western Regional Medical Center, Inc. Recruiting
Goodyear, Arizona, United States, 85338
Contact: Marci Pierog, OCN, CBCN    623-207-3818    marci.pierog@ctca-hope.com   
Principal Investigator: Jiaxin Niu, MD, PhD         
United States, California
St. Jude Heritage Recruiting
Fullerton, California, United States, 92835
Contact: William Lawler, MD    714-446-5900    William.Lawler@stjoe.org   
Contact: Gayle Madden-Mathes    714-446-5804    Gayle.Madden-MAthes@stjoe.org   
Principal Investigator: William Lawler, MD         
Marin Cancer Care, Inc. Recruiting
Greenbrae, California, United States, 94904
Contact: Jaime Chang, BS,CCRP    415-925-5040    jchang@marinspecialtycare.com   
Principal Investigator: Peter D. Eisenberg, MD         
The Thomas and Dorothy Leavey Cancer Center Recruiting
Northridge, California, United States, 91328
Contact: Sheldon Davidson, MD    818-885-8500      
Contact: Yacgley Valdes    818-885-8500 ext 2832    Yacgley.Valdes@DignityHealth.org   
Principal Investigator: Sheldon Davidson, MD         
Cancer Care Associates Medical Group Recruiting
Redondo Beach, California, United States, 90277
Contact: David Chan, MD    310-750-3376    drchan.cca@gmail.com   
Contact: Meg Fender    310-750-3376    mfender@mednet.ucla.edu   
Principal Investigator: David Chan, MD         
Coastal Integrative Cancer Care Recruiting
San Luis Obispo, California, United States, 93401
Contact: Brian DiCarlo, MD    805-543-5577      
Principal Investigator: Brian DiCarlo, MD         
Central Coast Medical Oncology Recruiting
Santa Maria, California, United States, 93454
Contact: Robert Dichmann, MD    805-349-9393    robert@ccmo.us   
Contact: Alison Fernandez    805-346-3461    alison.fernandez@dignityhealth.org   
Principal Investigator: Robert Dichmann, MD         
UCLA Recruiting
Santa Monica, California, United States, 90404
Contact: Sara Hurvitz, MD    310-829-5471    shurvitz@mednet.ucla.edu   
Contact: Monica Rocha    310-829-5471    mprocha@mednet.ucla.edu   
Principal Investigator: Sara Hurvitz, MD         
United States, Florida
Breast Cancer Center at Memorial Regional Hospital Recruiting
Hollywood, Florida, United States, 33021
Contact: Alejandra Perez, MD    954-265-4325    alperez@mhs.net   
Contact: Denise Francis    954-265-2796    dfrancis@mhs.net   
Principal Investigator: Alejandra Perez, MD         
United States, Indiana
Indiana University Health - Melvin and Bren Simon Cancer Center Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Lida Mina, MD       lmina@iu.edu   
Contact: LaTrice Vaughn, RN    317-278-3730    lgvaughn@iupui.edu   
Principal Investigator: Lida Mina, MD         
United States, Nevada
Comprehensive Cancer Centers of Nevada Recruiting
Henderson, Nevada, United States, 89014
Contact: Mary Ann Allison, MD    702-952-3395      
Contact: Donna Katz    702-952-3395      
Principal Investigator: Mary Ann Allison, MD         
United States, Texas
The University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
BioMarin Pharmaceutical
Translational Research in Oncology
Myriad Genetics, Inc.
  More Information

No publications provided

Responsible Party: BioMarin Pharmaceutical
ClinicalTrials.gov Identifier: NCT02034916     History of Changes
Other Study ID Numbers: 673-201
Study First Received: January 9, 2014
Last Updated: September 29, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by BioMarin Pharmaceutical:
Breast cancer
BRCA mutation
PARP inhibitor
BRCA 1
BRCA 2

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on October 22, 2014