{"entity":{"id":"olympia","kind":"trial","name":"OlympiA","aka":[],"tldr":"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.","status":"positive","asOf":"2026-09-04","links":[{"label":"ClinicalTrials.gov NCT02032823","url":"https://clinicaltrials.gov/study/NCT02032823"},{"label":"OlympiA overall survival (Annals of Oncology 2022)","url":"https://doi.org/10.1016/j.annonc.2022.09.159"},{"label":"NICE TA886 (10 May 2023)","url":"https://www.nice.org.uk/guidance/ta886"},{"label":"Lynparza label (openFDA): OlympiA eligibility and results","url":"https://api.fda.gov/drug/label.json?search=openfda.brand_name:%22LYNPARZA%22"}],"tags":[],"related":[],"cancers":["tnbc","breast-hr-positive","tnbc-early","hr-positive-early-high-risk"],"sections":[],"technologies":["parp-inhibitor"],"targets":["brca"],"drugs":["olaparib"],"companies":["nrg-oncology","big","breast-cancer-trials"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["andrew-tutt","charles-geyer","judy-garber"],"bottlenecks":[],"keyPapers":["paper-olympia-nejm-2021"],"journals":[],"dependsOn":[],"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."],"nct":"NCT02032823","phase":"3","setting":"Adjuvant olaparib for one year in germline BRCA-mutated, HER2-negative, high-risk early breast cancer","sponsor":"AstraZeneca / NRG / BIG","result":"iDFS HR 0.58; OS HR 0.72.","started":"2014-04-22","startedType":"actual","yearReported":2021,"enrolled":1837,"enrolledBasis":"registry","outcomes":[{"endpoint":"Invasive disease-free survival at 3 years","primary":true,"unit":"%","arms":[{"name":"Olaparib","n":921,"value":85.9},{"name":"Placebo","n":915,"value":77.1}],"hr":0.58,"ci":[0.41,0.82],"p":"<0.001","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2105215"},{"endpoint":"Overall survival at 4 years","unit":"%","arms":[{"name":"Olaparib","value":89.8},{"name":"Placebo","value":86.4}],"hr":0.68,"ci":[0.47,0.97],"p":"0.009","source":"https://www.annalsofoncology.org/article/S0923-7534(22)04165-7/fulltext"},{"endpoint":"Overall survival at 6 years","unit":"%","arms":[{"name":"Olaparib","value":87.5},{"name":"Placebo","value":83.2}],"hr":0.72,"ci":[0.56,0.93],"source":"https://clinicaltrials.gov/study/NCT02032823"}],"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)."},"route":"/trials/olympia/","neighbours":{"cancer":[{"id":"brca-associated-tnbc","kind":"cancer","name":"BRCA-associated triple-negative breast cancer","route":"/cancers/brca-associated-tnbc/"},{"id":"tnbc-early","kind":"cancer","name":"Early triple-negative breast cancer","route":"/cancers/tnbc-early/"},{"id":"hr-positive-early-high-risk","kind":"cancer","name":"High-risk early HR-positive breast cancer","route":"/cancers/hr-positive-early-high-risk/"},{"id":"breast-hr-positive","kind":"cancer","name":"HR-positive / HER2-negative breast cancer","route":"/cancers/breast-hr-positive/"},{"id":"inflammatory-breast-cancer","kind":"cancer","name":"Inflammatory breast cancer","route":"/cancers/inflammatory-breast-cancer/"},{"id":"male-breast-cancer","kind":"cancer","name":"Male breast cancer","route":"/cancers/male-breast-cancer/"},{"id":"tnbc","kind":"cancer","name":"Triple-negative breast cancer (TNBC)","route":"/cancers/tnbc/"}],"technology":[{"id":"parp-inhibitor","kind":"technology","name":"PARP inhibitors","route":"/technologies/parp-inhibitor/"}],"target":[{"id":"brca","kind":"target","name":"BRCA1 / BRCA2 (HRD)","route":"/targets/brca/"}],"drug":[{"id":"olaparib","kind":"drug","name":"Olaparib","route":"/drugs/olaparib/"}],"company":[{"id":"breast-cancer-trials","kind":"company","name":"Breast Cancer Trials","route":"/companies/breast-cancer-trials/"},{"id":"big","kind":"company","name":"Breast International Group (BIG)","route":"/companies/big/"},{"id":"nrg-oncology","kind":"company","name":"NRG Oncology","route":"/companies/nrg-oncology/"}],"person":[{"id":"andrew-tutt","kind":"person","name":"Andrew Tutt","route":"/people/andrew-tutt/"},{"id":"charles-geyer","kind":"person","name":"Charles E. Geyer Jr.","route":"/people/charles-geyer/"},{"id":"judy-garber","kind":"person","name":"Judy E. Garber","route":"/people/judy-garber/"}],"paper":[{"id":"paper-esmo-early-breast-cancer-guideline-ann-oncol-2024","kind":"paper","name":"Early breast cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up","route":"/key-papers/paper-esmo-early-breast-cancer-guideline-ann-oncol-2024/"},{"id":"paper-asco-hereditary-breast-cancer-guideline-jco-2020","kind":"paper","name":"Management of Hereditary Breast Cancer: American Society of Clinical Oncology, American Society for Radiation Oncology, and Society of Surgical Oncology Guideline","route":"/key-papers/paper-asco-hereditary-breast-cancer-guideline-jco-2020/"},{"id":"paper-olympia-nejm-2021","kind":"paper","name":"OlympiA: a year of olaparib after surgery for BRCA-mutated, high-risk early breast cancer","route":"/key-papers/paper-olympia-nejm-2021/"},{"id":"paper-olympia-overall-survival-ann-oncol-2022","kind":"paper","name":"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","route":"/key-papers/paper-olympia-overall-survival-ann-oncol-2022/"},{"id":"paper-olympia-6-year-update-ann-oncol-2026","kind":"paper","name":"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","route":"/key-papers/paper-olympia-6-year-update-ann-oncol-2026/"}],"term":[{"id":"gbrca-mutation","kind":"term","name":"Germline BRCA mutation (gBRCA)","route":"/terms/gbrca-mutation/"},{"id":"idfs","kind":"term","name":"Invasive disease-free survival (iDFS)","route":"/terms/idfs/"},{"id":"tnbc-residual-disease-decision","kind":"term","name":"Residual disease after neoadjuvant therapy in triple-negative breast cancer: the decision point","route":"/terms/tnbc-residual-disease-decision/"}],"roadmap":[{"id":"targeted-therapy-roadmap","kind":"roadmap","name":"Targeted therapy roadmap: imatinib → designed for resistance → the undruggable drivers fall","route":"/roadmaps/targeted-therapy-roadmap/"},{"id":"tnbc-history","kind":"roadmap","name":"TNBC roadmap: from 'nothing to target' to ADC + immunotherapy first line","route":"/roadmaps/tnbc-history/"},{"id":"tnbc-roadmap","kind":"roadmap","name":"Triple-negative breast cancer roadmap: from a remainder defined by three negative tests to immunotherapy, antibody-drug conjugates and the residual disease problem","route":"/roadmaps/tnbc-roadmap/"}],"idea":[{"id":"idea-tnbc-uk-trial-access-and-germline-testing-audit","kind":"idea","name":"A UK audit of trial access and germline testing uptake in triple-negative breast cancer","route":"/ideas/idea-tnbc-uk-trial-access-and-germline-testing-audit/"}],"pairing":[{"id":"germline-to-parp","kind":"pairing","name":"Germline BRCA test → adjuvant PARP inhibitor","route":"/pairings/germline-to-parp/"}],"bottleneck":[{"id":"b-hereditary-risk","kind":"bottleneck","name":"Inherited risk is mostly unidentified","route":"/bottlenecks/b-hereditary-risk/"}],"institution":[{"id":"guys-st-thomas","kind":"institution","name":"Guy's and St Thomas' NHS Foundation Trust / King's Health Partners Cancer Centre","route":"/institutions/guys-st-thomas/"}],"trial":[{"id":"nct04915755","kind":"trial","name":"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","route":"/trials/nct04915755/"}]}}