NSABP B55 Olaparib vs Placebo for Early Stage Breast Cancer

A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Multi-Centre 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

November 22, 2017

  • Clinical Trial Information

    Trial Contact: Pelley, Jennifer

    Trial Phone: 321.841.4348

  • IRB No: B-55

    Protocol Abbrev: B-55

    Principal Investigator: Nikita Chandrakant Shah, MD

    Sub Investigators: Baidas, Said MD; Moroose, Rebecca MD; Rostorfer, Regan MD; Shah, Nikita MD

    Phase: Drug: Phase III

    Age Group: Adult

    Secondary Protocol No: B-55

    Treatment: Olaparib Versus Placebo

    Applicable Disease Sites: Non-metastatic Breast Cancer

    Therapies Involved: Medication

    ClinicalTrials.gov ID: NCT02032823

  • Objective

    To assess the effect of adjuvant treatment with olaparib on Invasive Disease Free Survival (IDFS)

  • Key Eligibility

    Must have BRCA mutation and triple negative breast cancer.