NSABP B-55 BIG 6-13
Closed to Accrual & Treatment
Protocol Information
Tab containing protocol details, study design, and eligibility criteria
Tab containing study documents, informed consent forms, and study materials
Tab containing information for potential study participants
OlympiA: A Randomised, 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
Principal Investigator
Status
Closed to Accrual & Treatment
Date Opened To Accrual
July 3, 2014
Date Closed To Accrual
August 29, 2019
Disease Site
Breast [BR] Breast
Phase
III
Developmental Therapeutics
No
Primary Objective
To assess the effect of adjuvant treatment with olaparib on Invasive Disease Free Survival (IDFS)
Patient Population
Patients with germline BRCA mutations and HER2-negative primary breast cancer who are at high risk of recurrence and who have completed definitive local treatment and systemic neoadjuvant or adjuvant chemotherapy.
Target Accrual
1800
Protocol Documents
Available via the National Cancer Institute (NCI) Cancer Trials Support Unit (CTSU) website.
Investigator Brochure
- Olaparib_IB_Memo_101717.pdf
- Olaparib_IB_14.pdf
- Olaparib-IB-Update-Memo_11-05-18.pdf
- Olaparib-IB-Update-Memo_06-10-19.pdf
- MEMB-Olaparib-IB-AZD2281-Tracked-Edition-16-01-29-19.pdf
- MEMB-Olaparib-IB-AZD2281-Edition-Tracked-Edition-17-05-02-19.pdf
- MEMB-Olaparib-IB-AZD2281-Edition-16-Original-01-29-19.pdf
- MEMB-Olaparib-IB-AZD2281-Edition-17-Original-05-02-19.pdf
- MEMB-Olaparib-IB-AZD2281-Edition-15_03-8-18.pdf
- MEMB-Olaparib-IB-AZD2281-Edition-18-Original-01-29-20.pdf
- MEMB-Olaparib-IB-AZD2281-Edition-18-Tracked-Changes-01-29-20.pdf
- MEMB-Olaparib-IB-AZD2281-Edition-19-1.pdf
- MEMB-Olaparib-IB-AZD2281-Edition-19-tracked-changes-1.pdf
- MEMB-Olaparib-IB-AZD2281-Edition-20.pdf
- MEMB-Olaparib-IB-AZD2281-Edition-20-tracked-changes.pdf
- MEMB-Olaparib-IB-AZD2281-Edition-21.pdf
- MEMB-Olaparib-IB-AZD2281-Edition-21-tracked-changes.pdf
- MEMB-Olaparib-IB-AZD2281-Edition-21.1.pdf
- MEMB-Olaparib-IB-AZD2281-Edition-21.1-tracked-changes.pdf
- MEMB-ib-olaparib-edition-21.2.pdf
- MEMB-ib-olaparib-edition-21.2-tracked-changes-2.pdf
Patient Study Webpage
There is no available patient study webpage available for this trial at this time.