Disease × agent evidence record

Olaparib for Breast Cancer: evidence, trials and status

Olaparib has both completed registered trials and synthesis-level publications linked to Breast Cancer. That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit.

8 registered trials 2 recruiting 18 publications Evidence tier A · Strong Score 73.0
Research Tracker › Pairs › Breast Cancer › Olaparib
Research map, not treatment advice. This page aggregates registry and literature records. It does not evaluate efficacy, dosing or safety for any individual. Discuss any treatment decision with a qualified clinician.

Summary

Olaparib has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Breast Cancer would be drug repurposing rather than first-in-human development. This does not mean it is approved for Breast Cancer. ClinicalTrials.gov lists 8 registered trials linking Olaparib to Breast Cancer: 2 are currently recruiting; 1 is active or not yet recruiting; 3 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 2 (NCT06797635). It plans or enrolled 372 participants. Registration activity spans 2007 to 2025. The literature layer holds 18 publications for this pair: 5 Cochrane reviews, 4 meta-analyses, 1 systematic review, 3 randomised controlled trial publications and 5 clinical trial publications. Publication years run from 2022 to 2026. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.

The RepurpOS disease-intelligence file for Breast Cancer ranks 1462 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: Spontaneous regression documented but rare (<0.5%); 5-year survival stage I: ~99%; stage IV: ~28% overall, improving with modern therapy.

Open in Repurposing ExplorerBreast Cancer hubBreast Cancer biomarkers & interventions

Evidence table

Evidence tierA · Strong
Evidence score73.0 (trials 23.0, literature 30.0, tier 15, approved bonus 5.0)
Registered trials8 total: 2 recruiting, 1 active / not yet recruiting, 3 completed, 2 other
Linked publications18 (5 Cochrane reviews, 5 clinical trial publications, 4 meta-analyses, 3 randomised controlled trial publications, 1 systematic review)
Agent typeDrug (Small molecule)
Development stage (any indication)Approved
Mechanism / classNot recorded
Data sourcesDGIdb
Linked via biomarker / targetBRCA1
How the evidence score is calculated
  • Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
  • Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
  • The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
  • Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
  • The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.

Registered clinical trials

NCT IDTitleStatusPhaseEnrolment
NCT06175390Tiragolumab, Atezolizumab and Chemotherapy in Triple Negative Breast Cancer
2024
active, not recruitingPhase 281
NCT06797635Study of Patritumab Deruxtecan Plus Pembrolizumab With Other Anticancer Agents in Participants With High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/HER-2 Negative Breast Cancer (MK-1022-010, HERTHENA-Breast-03)
2025
recruitingPhase 2372
NCT05174832Induction of Cisplatin/Nab-paclitaxel/Pembrolizumab Followed by Olaparib/Pembrolizumab Maintenance in mTNBC Patients
2022
status unknownPhase 2136
NCT01445418AZD2281 Plus Carboplatin to Treat Breast and Ovarian Cancer
2008
completedPhase 1103
NCT00516724Study to Assess the Safety and Tolerability of a PARP Inhibitor in Combination With Carboplatin and/or Paclitaxel
2007
completedPhase 1189
NCT02898207Olaparib and Onalespib in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery or Recurrent Ovarian, Fallopian Tube, Primary Peritoneal, or Triple-Negative Breast Cancer
2017
completedPhase 128
NCT02561832A Phase I, Open-Label, 2 Part Multicentre Study to Assess the Safety and Efficacy of Olaparib in Combination With Carboplatin in Patients With Advanced HER-2 Negative Breast Cancer
2015
terminatedPhase 115
NCT06197581Safety Assessment of Concurrent Radiotherapy and Novel Systemic Therapy for Breast Cancer
2024
recruitingNot applicable148

Search ClinicalTrials.gov for newer studies

Published literature

Run the live PubMed search

Mechanism and notes

No mechanism of action is recorded for this pair in the source databases.

OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target BRCA1. The tier describes how well the drug-disease link is documented, not how well the drug works.

Frequently asked questions

Is Olaparib approved for Breast Cancer?

Olaparib has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Breast Cancer would be drug repurposing rather than first-in-human development. This does not mean it is approved for Breast Cancer. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.

Is Olaparib in clinical trials for Breast Cancer?

ClinicalTrials.gov lists 8 registered trials linking Olaparib to Breast Cancer: 2 are currently recruiting; 1 is active or not yet recruiting; 3 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 2 (NCT06797635). It plans or enrolled 372 participants. Registration activity spans 2007 to 2025.

What does the evidence show for Olaparib in Breast Cancer?

Olaparib has both completed registered trials and synthesis-level publications linked to Breast Cancer. That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in DGIdb, in this case via the biomarker or target BRCA1. The tier describes how well the drug-disease link is documented, not how well the drug works.

Cite this page

Open Source Medicine Foundation. Olaparib for Breast Cancer: evidence, trials and status. OSMF Research Tracker. Updated 2026-07-05. https://research.opensourcemed.info/pairs/breast-cancer/olaparib.html

Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.

Get OSMF research updates on Substack

This is a research map, not treatment advice. Evidence tiers and scores summarise what has been studied, not whether a treatment works or is safe for you.