Breast Cancer: NSABP B-55 (Iowa Cancer Specialists)

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

Objective

The purpose of this study is to compare the addition of olaparib after the usual care of chemotherapy, surgery, and radiation for patients with breast cancer who have been found to carry a BRCA1 or BRCA2 mutation in their genes and have a type of breast cancer that is HER2-negative and is not sensitive to hormone treatment or is HER2-negative and is sensitive to hormone treatment.  

If the cancer is sensitive to hormone treatment, the participant may receive hormone drugs as part of usual care. In this study, patients will get either
olaparib or placebo, a pill that looks like the study drug but contains no
medication. 

The use of olaparib could reduce the risk of cancer coming back but it could also cause side effects.  To be better than placebo, the olaparib should decrease the chance of cancer coming back as compared to the placebo.

Principal Investigator(s)
George Kovach

Clinical Trial Categories

  • Breast Cancer
Sponsor(s)
National Surgical Adjuvant Breast and Bowel Project
Contact
Kim Turner, R.N. at 563-421-1908
or turnerk@genesishealth.com

Location

  • Medical Center, West Central Park
    1401 West Central Park
    Davenport, IA 52804
    Main: 563-421-1000

Contact Us

For more information about our research program and IRB, please contact:

Research Support Office
563-421-7955

Email