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NSABP B-55 / BIG 6-13

NSABP B-55/BIG 6-13 [OlympiA]

NSABP B-55/BIG 6-13 [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 Investigators

Charles Geyer, Jr., MD

Judy Garber, MD

Primary Objectives

  • 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

  • Randomized:  1500 worldwide; 330 in the US

Status

     Activated      7/3/2014

Protocol and Other Documents

Available via the National Cancer Institute (NCI) Cancer Trials Support Unit (CTSU) website
Investigator's Brochure
is available via the NSABP website (or through the CTSU.)
Site Initiation Visit (SIV)
Video:  To access the site initiation (SIV) video* click here.
Slide Sets*
are posted to the NRG Oncology B-55 page.
OlympiAD Investigator Letter and Press Release* are posted to the NRG Oncology B-55 page.

*You will be prompted to enter your CTEP IAM credentials to access the materials.

 

 



 

 


H. Jin Byun
Jenna Carmichael
Tali Johnson
Suwicha Limvorasak
Robin Lockhorst  
Patrick Medina
Roisin Oceanrbhaill
Wendy Wong  

 

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