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To Assess Safety and Efficacy of Agents Targeting DNA Damage Repair With Olaparib Versus Olaparib Monotherapy.

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NCT03330847 · results posted

Sponsored by AstraZeneca (industry) · AZN — their whole pipeline →.

Phase
Phase 2
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
273actual
Sites
141
Countries
Belgium, Canada, Czechia +12

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
DateFiledBasisWhat it is
Start2018-03-07actualWhen the study began enrolling
Primary completion2020-11-13actualThe date the last participant is measured for the primary outcome — the readout window
Study completion2026-10-09estimatedThe whole study's end, after follow-up
First posted2017-11-06actualWhen this record first appeared on the registry
Results posted2022-03-22actualWhen the sponsor posted results to the registry
Record updated2026-07-02actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Condition

  • Metastatic Triple Negative Breast Cancer

Interventions

  • Drug: Olaparib Continuous (28-Day cycle) 300 mg BD.
  • Drug: Ceralasertib 160 mg OD + olaparib continuous 300 mg BD (28-day cycle).
  • Drug: Adavosertib 150 mg BD + olaparib 200 mg BD (21-day cycle).

Primary outcomes

what the primary-completion date above is the date OF
Progression-free Survival Per Stratum (BICR)
measured Until date of first documented progression or censoring date or date of death from any cause, whichever came first (assessed up to 32 months)
Progression-free Survival Per Stratum (Sensitivity Analysis)
measured Until date of first documented progression or censoring date or date of death from any cause, whichever came first (assessed up to 32 months)

Posted documents

hosted by the registry — we link, never re-serve
Study Protocolposted 2020-05-06 · 1.5 MB · Prot_000.pdf
Statistical Analysis Planposted 2019-06-14 · 2.1 MB · SAP_001.pdf

Publications

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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