A newer report of this study has been published: 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 (2026)
For women (and men) with an inherited BRCA1 or BRCA2 mutation who have had high-risk HER2-negative breast cancer, taking olaparib tablets for one year after finishing chemotherapy and surgery lowered the risk of the cancer coming back and helped patients live longer. This is why BRCA genetic testing matters for treatment in eligible patients.
Germline BRCA1/2 mutation, HER2-negative, high risk, after completion of neoadjuvant or adjuvant chemotherapy and local treatment
| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Olaparib | 300 mg twice daily | Oral | Continuous |
Start only after haematologic toxicity from prior chemotherapy has recovered to grade 1 or lower.
After neoadjuvant or adjuvant chemotherapy
| Drug | Dose | Route | Schedule |
|---|---|---|---|
| Continuous | |||
| Olaparib | 300 mg | Oral (with or without food) | Twice daily (about every 12 hours) |
In hormone receptor-positive disease, continue concurrent endocrine therapy as per guidelines.
On the page “Olaparib (Lynparza)” · Standard dosing (FDA label)
Doses follow the trial protocol, guideline or official drug label (source given in the notes of each regimen). Before prescribing, check blood counts, renal and hepatic function, drug interactions and the patient’s condition, and adjust the dose according to the drug label.
Olaparib tablets 300 mg orally twice daily (two 150 mg tablets about 12 hours apart) for 1 year.
Placebo tablets twice daily for 1 year.
Source of the regimen details: ClinicalTrials.gov NCT02032823 (300 mg twice daily) and abstract of the paper (duration 1 year)
Doses are given for the information of specialists, as in this study’s protocol, and are not a prescription. Every drug must be prescribed by the treating physician for the individual patient.
Patients with early HER2-negative breast cancer with a germline pathogenic or likely pathogenic BRCA1 or BRCA2 variant and high-risk clinicopathological factors, who had completed local treatment and neoadjuvant or adjuvant chemotherapy.
Primary endpoint: invasive disease-free survival (iDFS). Secondary: distant disease-free survival, overall survival, safety and quality of life.
Safety data were consistent with the known adverse events of olaparib (nausea, fatigue, anaemia), with no increase in serious adverse events or adverse events of special interest. In the overall survival analysis, no new cases of acute myeloid leukaemia or myelodysplastic syndrome were reported. The effect on global quality of life was limited.
In March 2022 the FDA approved adjuvant olaparib for high-risk HER2-negative early breast cancer with a germline BRCA mutation. The overall survival analysis (Geyer et al., Ann Oncol 2022) showed a significant survival improvement. ESMO guideline (Pan-Asian adapted version 2024): one year of adjuvant olaparib is recommended for patients with a germline BRCA1/2 mutation and high-risk TNBC [I, A] or high-risk HR-positive disease [I, A]; and germline testing should be offered to candidates for adjuvant olaparib [I, A].
Only patients with germline (not somatic) BRCA1/2 mutations were enrolled; HR-positive patients were under-represented; most patients were treated before neoadjuvant pembrolizumab and adjuvant capecitabine became widespread.
This summary was prepared by the editorial team from the published paper; the original paper is the final reference. Read the original abstract on PubMed.
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