ABCSG 41 / OlympiA
Status: Treatment Phase & Follow-up
A randomised, double-blind, parallel group, placebo-controlled multi-centre phase III study to assess the efficacy and safety of olaparib vs placebo as adjuvant treatment in patients with germline BRCA1/2 mutations and high risk HER2-negative breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy
| Coordinating Investigator: | Christian Singer (Vienna) |
| Start of study: | 03/2017 (global), 01/2015 (national) |
| Sample size: | 1.800 |
| Sponsor: | AstraZeneca |
Description and status:
This international study project, exploring the efficacy and safety of study medication olaparib, recruited HER2-negative high-risk breast cancer patients with germline BRCA1/2 mutations. This AstraZeneca sponsored trial reached its global end of recruitment on May 28th, 2019. According to the current study protocol, the study will last until 2028. Globally, a total of 1836 patients were randomized. The initially planned recruitment target of the participating Austrian trial sites was 47 patients and due to the excellent recruitment activity, a total of 53 Austrian patients could be enrolled up until end of recruitment. The results of the analysis of the primary endpoint (Invasive Disease-Fee Survival, IDFS) were published on June 3rd, 2021 in the New England Journal of Medicine. The study met the pre-specified criteria for superiority for the primary endpoint and no safety signals of concern were noted. In March 2022, the study sponsor announced the results of the second interim analysis of overall survival (OS), which showed that one year of adjuvant olaparib, relative to placebo, led to statistically significant and clinically meaningful improvement of OS. Olaparib is now approved by the US FDA for adjuvant treatment of patients with BRCA-mutated HER2-negative high risk early breast cancer who have already been treated with chemotherapy either before or after surgery.
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