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NSABP B-55/BIG 6-13 for BRCA1/2 Mutations and High Risk HER2 Negative Breast Cancer - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out how safe and effective the drug called olaparib is with additional approaches to keep cancer from returning. After treatment is complete you will be watched for side effects and your condition monitored for 10 years.

What is the Condition Being Studied?

Breast cancer

Who Can Participate in the Study?

Adults 18 years or older, who:
- Have undergone surgery and received adjuvant chemoterapy
- Have undergone neoadjuvant chemotherapy followed by surgery
- Have histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast
- Have BRCA mutation

Age Group
Adults

What is Involved?

If you agree to be in the study, you will:
- Be tested for a BRCA mutation - requires a sample of tissue from your previous biopsy/surgery
- Be randomized (put into one of two groups by chance like the flip of a coin) to receive study drug or placebo
-- Take your assigned treatment (olaparib or placebo) for about 12 months
- Have a blood test before, during, and after your treatment period
- Have an electrocardiogram (ECG)

Study Details

Full Title
NSABP B-55/BIG 6-13: A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Multi-Center Phase III Study to Assess the Efficacy and Safety of Olaparib Versus Placebo as Adjuvant Treatment in Patients with Germline BRCA1/2 Mutations and High Risk HER2 Negative Primary Breast Cancer Who Have Completed Definitive Local Treatment and Neoadjuvant or Adjuvant Chemotherapy
Principal Investigator
Medical Oncologist
Protocol Number
IRB:PRO00061408
NCT:NCT02032823
Phase
Phase III
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
studyrecruitment@duke.edu
or
919-681-5698