Summary
Rucaparib 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 ClinicalTrials.gov lists 8 registered trials linking Rucaparib to Breast Cancer: 5 have completed; 3 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 2 (NCT04171700). The largest enrolment is 137 participants (NCT02711137). Registration activity spans 2007 to 2020. The literature layer holds 10 publications for this pair: 1 Cochrane review, 3 meta-analyses, 1 systematic review and 5 clinical trial publications. Publication years run from 2016 to 2025. 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.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 68.5 (trials 18.5, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 0 recruiting, 0 active / not yet recruiting, 5 completed, 3 other |
| Linked publications | 10 (5 clinical trial publications, 3 meta-analyses, 1 Cochrane review, 1 systematic review) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | DGIdb |
| Linked via biomarker / target | BRCA1 |
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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT00664781 | Rucaparib(CO-338;Formally Called AG-014699 or PF-0136738) in Treating Patients With Locally Advanced or Metastatic Breast Cancer or Advanced Ovarian Cancer 2007 | completed | Phase 2 | 78 |
| NCT02505048 | A Study to Assess the Efficacy of Rucaparib in Metastatic Breast Cancer Patients With a BRCAness Genomic Signature 2016 | completed | Phase 2 | 41 |
| NCT04171700 | A Study to Evaluate Rucaparib in Participants With Solid Tumors and With Deleterious Mutations in HRR Genes 2020 | terminated | Phase 2 | 83 |
| NCT03542175 | A Study of Rucaparib Administered With Radiation in Patients With Triple Negative Breast Cancer With an Incomplete Response Following Chemotherapy 2018 | completed | Phase 1 | 31 |
| NCT03101280 | A Combination Study of Rucaparib and Atezolizumab in Participants With Advanced Gynecologic Cancers and Triple-Negative Breast Cancer 2017 | completed | Phase 1 | 29 |
| NCT03911453 | Window of Opportunity Trial, PARP Inhibitor Rucaparib Affect on PD-L1 Expression in Triple Negative Breast Tumors 2019 | completed | Early Phase 1 | 20 |
| NCT02711137 | Open-Label Safety and Tolerability Study of INCB057643 in Subjects With Advanced Malignancies 2016 | terminated | PHASE1, PHASE2 | 137 |
| NCT03992131 | A Study to Evaluate Rucaparib in Combination With Other Anticancer Agents in Participants With a Solid Tumor (SEASTAR) 2019 | terminated | PHASE1, PHASE2 | 25 |
Published literature
- Meta-analysis Neurological toxicities with poly (ADP-ribose) polymerase inhibitors in cancer patients: a systematic review and meta-analysisJin W, Zhang Z, Sun W et al. · Journal of chemotherapy (Florence, Italy) · 2025 · PMID 39180239
- Clinical trial publication PARP inhibition with rucaparib alone followed by combination with atezolizumab: Phase Ib COUPLET clinical study in advanced gynaecological and triple-negative breast cancersKristeleit R, Leary A, Oaknin A et al. · British journal of cancer · 2024 · PMID 38971950
- Clinical trial publication A Phase II Study of Rucaparib Monotherapy in Nonmetastatic, Hormone-Sensitive Prostate Cancer Demonstrating "BRCAness" Genotype (ROAR)Sahu KK, Li H, Mathew Thomas V et al. · The oncologist · 2024 · PMID 38452035
- Meta-analysis Poly (ADP-ribose) Polymerase Inhibitors Have Comparable Efficacy with Platinum Chemotherapy in Patients with BRCA-positive Metastatic Castration-resistant Prostate Cancer. A Systematic Review and Meta-analysisFazekas T, Széles ÁD, Teutsch B et al. · European urology oncology · 2024 · PMID 37722977
- Cochrane review Cost-effectiveness of PARP inhibitors in malignancies: A systematic reviewDing H, He C, Tong Y et al. · PloS one · 2022 · PMID 36520958
- Systematic review The Molecular Mechanisms of Actions, Effects, and Clinical Implications of PARP Inhibitors in Epithelial Ovarian Cancers: A Systematic ReviewLau CH, Seow KM, Chen KH · International journal of molecular sciences · 2022 · PMID 35897700
- Clinical trial publication Rucaparib in patients presenting a metastatic breast cancer with homologous recombination deficiency, without germline BRCA1/2 mutationPatsouris A, Diop K, Tredan O et al. · European journal of cancer (Oxford, England : 1990) · 2021 · PMID 34837859
- Meta-analysis Poly (ADP-ribose) polymerase inhibitors in solid tumours: Systematic review and meta-analysisSchettini F, Giudici F, Bernocchi O et al. · European journal of cancer (Oxford, England : 1990) · 2021 · PMID 33862496
- Clinical trial publication Homologous recombination DNA repair deficiency and PARP inhibition activity in primary triple negative breast cancerChopra N, Tovey H, Pearson A et al. · Nature communications · 2020 · PMID 32471999
- Clinical trial publication Phase 2 multicentre trial investigating intermittent and continuous dosing schedules of the poly(ADP-ribose) polymerase inhibitor rucaparib in germline BRCA mutation carriers with advanced ovarian and breast cancerDrew Y, Ledermann J, Hall G et al. · British journal of cancer · 2016 · PMID 27002934
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 Rucaparib approved for Breast Cancer?
Rucaparib 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 Rucaparib in clinical trials for Breast Cancer?
ClinicalTrials.gov lists 8 registered trials linking Rucaparib to Breast Cancer: 5 have completed; 3 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 2 (NCT04171700). The largest enrolment is 137 participants (NCT02711137). Registration activity spans 2007 to 2020.
What does the evidence show for Rucaparib in Breast Cancer?
Rucaparib 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
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.