OlympiA (BIG 6-13)

Intro text: 

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


ClinicalTrials.gov Identifier: NCT02032823

OlympiA will assess if a new treatment using a drug called olaparib can reduce the risk of breast cancer recurrence in patients with high-risk HER2-negative primary breast cancer who have an inherited BRCA1 or BRCA2 gene mutation and who have completed all standard anticancer treatments. 

Olaparib aims to block the repair of DNA which can cause cancer cells to die. 

Several previous studies have already shown that the use of the drug olaparib improves the chance of disease-free survival of patients with inherited BRCA1 or BRCA2 mutations who have advanced cancers. Other studies have shown that olaparib significantly reduces the risk of progression in patients with recurrent ovarian cancer.

The main objective of OlympiA is to assess the effect of post-surgery treatment with olaparib on invasive disease-free survival. This also includes assessing the safety and tolerability of post-surgery treatment with olaparib.

Based on the planned interim analysis, the IDMC concluded that the trial crossed the superiority boundary for its primary endpoint of invasive disease-free survival (iDFS) and demonstrated a sustainable, clinically relevant treatment effect for olaparib (Lynparza) versus placebo for patients with germline BRCA-mutated (gBRCAm) high-risk human epidermal growth factor receptor 2 (HER2)-negative early breast cancer, and recommend primary analysis now take place. 

The OlympiA Phase III trial will move to early primary analysis and reporting. 

In its communication, the IDMC did not raise any new safety concerns. The trial will continue to assess the key secondary endpoints of overall survival and distant disease-free survival.

Read the announcement issued on 17 February 2021

Patients enrolled in OlympiA were randomly assigned to one of the following treatment groups and received treatment for up to 12 months: 
- olaparib 
- placebo

The study will compare results between the two treatment groups, looking at the invasive disease-free survival, distant disease-free survival, overall survival, safety, patient functioning and health related quality of life.

All randomised patients will have clinical assessment visits for 10 years following their randomisation into the study. Once a patient completes 10 years of clinical assessment, she/he will enter the survival follow-up phase of the trial which will continue until 10 years after the last patient is randomised.

During the trial, DNA samples (blood and tumour tissue) will be collected from all participating patients and stored in the study biorepository for future research into genes/genetic variation.

The study was opened to recruitment in 2014 and completed recruitment in 2019.

Over 600 hospitals activated in 23 countries around the globe.

Patients who have been diagnosed with high-risk HER2-negative primary breast cancer, who carry BRCA1 or BRCA2 mutations in their genes, and who have completed definitive local treatment, and pre- or post-surgery chemotherapy.

A total of 1,836 patients have been enrolled in the study. 

This is a collaborative study being coordinated worldwide by BIG, in partnership with Frontier Science & Technology Research Foundation (FSTRF), NRG Oncology (NCI supported National Clinical Trials Network Group) and AstraZeneca (AZ).

21 research groups from the BIG network are participating in this trial: ABCSG, AGO-B, BCT-ANZ, BOOG, CCTG, CEEOG, EORTC , GAICO, GBG, GEICAM, GOIRC, IBCG, IBCSG, ICR-CTSU, JBCRG, SABO, SOLTI,  SUCCESS, SweBCG, TCOG, UCBG (FBSG)

The study is funded by AstraZeneca. The study sponsors are NRG Oncology (US) and AstraZeneca (rest of the world). 

The study is run according to BIG's Principles of Research Conduct.