Olaparib as Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer
← catalyst calendarSponsored by AstraZeneca (industry) · AZN — their whole pipeline →. With Frontier Science & Technology Research Foundation, Inc., NRG Oncology, Myriad Genetic Laboratories, Inc., The Breast Adjuvant Study Team and 1 more.
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · Triple · Treatment
Enrollment
1,837actual
Sites
698
Countries
Argentina, Australia, Austria +21
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2014-04-22 | actual | When the study began enrolling |
| Primary completion | 2020-03-27 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2029-05-28 | estimated | The whole study's end, after follow-up |
| First posted | 2014-01-10 | estimated | When this record first appeared on the registry |
| Results posted | 2021-12-08 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-07-14 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Breast Cancer
Interventions
- Drug: Olaparib — also filed as Lynparza
- Drug: Placebo
Primary outcome
what the primary-completion date above is the date OFInvasive Disease Free Survival (IDFS)
measured From date of randomisation to data cut off: 27 March 2020 (approximately 5 years 11 months)
Posted documents
hosted by the registry — we link, never re-serveStudy Protocol and Statistical Analysis Planposted 2021-05-06 · 27.3 MB · Prot_SAP_000.pdf
Publications
- PMID 38301187 — linked by the registry
- PMID 35594464 — linked by the registry
- PMID 34081848 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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