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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) (ABRAZO)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Myriad Genetic Laboratories, Inc.
Medivation, Inc.
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT02034916
First received: January 9, 2014
Last updated: August 10, 2017
Last verified: August 2017
January 9, 2014
August 10, 2017
December 13, 2013
September 1, 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 ]
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 ]
  • Duration of response (DOR) for objective responders [ Time Frame: Anticipated in about 24-30 months following first patient enrolled ]
  • Progression Free Survival (PFS) [ Time Frame: Anticipated in about 24-30 months following first patient enrolled ]
  • Overall survival (OS) [ Time Frame: Anticipated in about 24-30 months following first patient enrolled ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Duration of response (DOR) for objective responders [ Time Frame: Anticipated in about 24-30 months following first patient enrolled ]
  • Progression Free Survival (PFS) [ Time Frame: Anticipated in about 24-30 months following first patient enrolled ]
  • Overall survival (OS) [ Time Frame: Anticipated in about 24-30 months following first patient enrolled ]
Health-related quality of life [ Time Frame: Anticipated in about 24-30 months following first patient enrolled ]
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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Breast Neoplasms
  • BRCA 1 Gene Mutation
  • BRCA 2 Gene Mutation
Drug: talazoparib
Other Names:
  • MDV3800
  • BMN673
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
85
December 31, 2017
September 1, 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
France,   Germany,   Spain,   United Kingdom,   United States
 
 
NCT02034916
673-201
2013-003076-12 ( EudraCT Number )
C3441008 ( Other Identifier: Alias Study Number )
Not Provided
Not Provided
Not Provided
Pfizer
Pfizer
  • Myriad Genetic Laboratories, Inc.
  • Medivation, Inc.
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
August 2017

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