Study of Neoadjuvant Olaparib Monotherapy and Olaparib and Durvalumab Combination in HER2 Negative BRCAm Breast Cancer
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Phase
Phase 2
Status
Active, not recruiting
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
50actual
Sites
37
Countries
Australia, Austria, Belgium +6
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 | 2022-11-07 | actual | When the study began enrolling |
| Primary completion | 2024-11-20 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-12-31 | estimated | The whole study's end, after follow-up |
| First posted | 2022-08-11 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-07 | 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: Neoadjuvant Olaparib monotherapy group — also filed as Cohort A
- Combination product: Neoadjuvant combination therapy with olaparib plus durvalumab — also filed as Cohort B
Primary outcome
what the primary-completion date above is the date OFTo evaluate the efficacy, measured by pCR (pathological complete response) rate, of olaparib monotherapy and olaparib plus durvalumab combination therapy, as assessed by central pathology review.
measured Approx. 4 to 6 months
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2024-04-14 · 21.9 MB · Prot_000.pdf
Statistical Analysis Planposted 2022-12-01 · 4.9 MB · SAP_001.pdf
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