# OlympiA

Source: https://onco.cc/trials/olympia/  
OnCo record `olympia` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Showed that a year of a PARP inhibitor after standard treatment improves survival in women with inherited BRCA mutations.

## Summary

OlympiA, trial NCT02032823 sponsored by AstraZeneca, NRG Oncology and the Breast International Group and published in the New England Journal of Medicine in 2021, showed that a year of the PARP inhibitor olaparib after standard treatment improves survival in women with germline BRCA mutations and high-risk, HER2-negative early breast cancer, about eighty percent of whom had triple-negative disease. It randomised 1,836 patients to olaparib or placebo, met its primary invasive disease-free survival endpoint and showed an overall survival benefit that was sustained at six years. It makes germline testing a treatment decision for every such patient, and whether the benefit extends to somatic or non-BRCA HRD alterations is the open question.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-04
- Registry id: NCT02032823
- Phase: 3
- Setting: Adjuvant olaparib for one year in germline BRCA-mutated, HER2-negative, high-risk early breast cancer
- Sponsor: AstraZeneca / NRG / BIG
- Enrolled: 1837
- Result: iDFS HR 0.58; OS HR 0.72.
- Outcomes: Invasive disease-free survival at 3 years: Olaparib 85.9% vs Placebo 77.1%, HR 0.58; Overall survival at 4 years: Olaparib 89.8% vs Placebo 86.4%, HR 0.68; Overall survival at 6 years: Olaparib 87.5% vs Placebo 83.2%, HR 0.72
- Replication: Single pivotal adjuvant trial with a sustained OS benefit at 6 years; consistent with the metastatic-setting PFS benefit of olaparib (OlympiAD) and talazoparib (EMBRACA).

## Notes

- Second interim overall survival analysis (Annals of Oncology 2022, median follow-up 3.5 years): hazard ratio 0.68 (98.5 percent confidence interval 0.47 to 0.97, p 0.009), four-year overall survival 89.8 versus 86.4 percent, four-year invasive disease-free survival 82.7 versus 75.4 percent, distant disease-free survival 86.5 versus 79.1 percent; no new cases of acute myeloid leukaemia or myelodysplasia. Eligibility (Lynparza label): triple-negative patients needed residual invasive disease after neoadjuvant chemotherapy, or node-positive disease or a tumour of 2 cm or more after adjuvant chemotherapy; 82 percent of the trial was triple-negative. UK: 22 registry sites; NICE TA886 (10 May 2023) commissions the year of olaparib.

## Sources

- ClinicalTrials.gov NCT02032823: https://clinicaltrials.gov/study/NCT02032823
- OlympiA overall survival (Annals of Oncology 2022): https://doi.org/10.1016/j.annonc.2022.09.159
- NICE TA886 (10 May 2023): https://www.nice.org.uk/guidance/ta886
- Lynparza label (openFDA): OlympiA eligibility and results: https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22LYNPARZA%22

## Connected records

- cancers: [BRCA-associated triple-negative breast cancer](https://onco.cc/cancers/brca-associated-tnbc/), [Early triple-negative breast cancer](https://onco.cc/cancers/tnbc-early/), [High-risk early HR-positive breast cancer](https://onco.cc/cancers/hr-positive-early-high-risk/), [HR-positive / HER2-negative breast cancer](https://onco.cc/cancers/breast-hr-positive/), [Inflammatory breast cancer](https://onco.cc/cancers/inflammatory-breast-cancer/), [Male breast cancer](https://onco.cc/cancers/male-breast-cancer/), [Triple-negative breast cancer (TNBC)](https://onco.cc/cancers/tnbc/)
- technologies: [PARP inhibitors](https://onco.cc/technologies/parp-inhibitor/)
- targets: [BRCA1 / BRCA2 (HRD)](https://onco.cc/targets/brca/)
- drugs: [Olaparib](https://onco.cc/drugs/olaparib/)
- companies: [Breast Cancer Trials](https://onco.cc/companies/breast-cancer-trials/), [Breast International Group (BIG)](https://onco.cc/companies/big/), [NRG Oncology](https://onco.cc/companies/nrg-oncology/)
- people: [Andrew Tutt](https://onco.cc/people/andrew-tutt/), [Charles E. Geyer Jr.](https://onco.cc/people/charles-geyer/), [Judy E. Garber](https://onco.cc/people/judy-garber/)
- key papers: [Early breast cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up](https://onco.cc/key-papers/paper-esmo-early-breast-cancer-guideline-ann-oncol-2024/), [Management of Hereditary Breast Cancer: American Society of Clinical Oncology, American Society for Radiation Oncology, and Society of Surgical Oncology Guideline](https://onco.cc/key-papers/paper-asco-hereditary-breast-cancer-guideline-jco-2020/), [OlympiA: a year of olaparib after surgery for BRCA-mutated, high-risk early breast cancer](https://onco.cc/key-papers/paper-olympia-nejm-2021/), [Overall survival in the OlympiA phase III trial of adjuvant olaparib in patients with germline pathogenic variants in BRCA1/2 and high-risk, early breast cancer](https://onco.cc/key-papers/paper-olympia-overall-survival-ann-oncol-2022/), [Sustained benefit of adjuvant olaparib in women with germline BRCA1- and BRCA2-associated high-risk HER2-negative early breast cancer: updated results from the OlympiA phase III trial](https://onco.cc/key-papers/paper-olympia-6-year-update-ann-oncol-2026/)
- terms: [Germline BRCA mutation (gBRCA)](https://onco.cc/terms/gbrca-mutation/), [Invasive disease-free survival (iDFS)](https://onco.cc/terms/idfs/), [Residual disease after neoadjuvant therapy in triple-negative breast cancer: the decision point](https://onco.cc/terms/tnbc-residual-disease-decision/)
- roadmaps: [Targeted therapy roadmap: imatinib → designed for resistance → the undruggable drivers fall](https://onco.cc/roadmaps/targeted-therapy-roadmap/), [TNBC roadmap: from 'nothing to target' to ADC + immunotherapy first line](https://onco.cc/roadmaps/tnbc-history/), [Triple-negative breast cancer roadmap: from a remainder defined by three negative tests to immunotherapy, antibody-drug conjugates and the residual disease problem](https://onco.cc/roadmaps/tnbc-roadmap/)
- ideas: [A UK audit of trial access and germline testing uptake in triple-negative breast cancer](https://onco.cc/ideas/idea-tnbc-uk-trial-access-and-germline-testing-audit/)
- pairings: [Germline BRCA test → adjuvant PARP inhibitor](https://onco.cc/pairings/germline-to-parp/)
- bottlenecks: [Inherited risk is mostly unidentified](https://onco.cc/bottlenecks/b-hereditary-risk/)
- institutions: [Guy's and St Thomas' NHS Foundation Trust / King's Health Partners Cancer Centre](https://onco.cc/institutions/guys-st-thomas/)
- trials: [Efficacy and Safety Comparison of Niraparib to Placebo in Participants With Human Epidermal Growth Factor 2 Negative (HER2-) Breast Cancer Susceptibility Gene Mutation (BRCAmut) or Triple-Negative Breast Cancer (TNBC) With Molecular Disease](https://onco.cc/trials/nct04915755/)

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JSON: https://onco.cc/api/v1/entities/olympia.json