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B55 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 (D081CC00006)
Protocol Number:
Phase III
Deborah Armstrong
Johns Hopkins Kimmel Cancer Center in Baltimore
Sibley Memorial Hospital
Suburban Hospital
The purpose of this study is to compare the addition of olaparib after the usual care of chemotherapy, surgery, and radiation for your type of cancer.
Generally healthy adults with triple negative breast cancer who have had surgery and chemotherapy and do not have metastatic disease may be eligible to join. BRCA testing can be done but is not required in order to participate.
Patients who do not know their BRCA results will be tested. Patients with known deletions will be randomized to receive Olaparib or placebo (an inactive pill) to take twice daily for 12 months. The study doctor, nor the patient will know what the patient is taking. The patient will be seen about once a month for six months and then every 3 months while taking the study drug for routine clinical monitoring. All patients will be followed long-term for recurrence.
Last Update
03/05/2019 05:03 AM