Summary
Cisplatin 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 Cisplatin to Breast Cancer: 1 is currently recruiting; 2 are active or not yet recruiting; 2 have completed; 3 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 3 (NCT02879513). It plans or enrolled 290 participants. Registration activity spans 1998 to 2026. The literature layer holds 16 publications for this pair: 5 Cochrane reviews, 4 meta-analyses, 1 systematic review, 1 randomised controlled trial publication 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.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 72.5 (trials 22.5, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 1 recruiting, 2 active / not yet recruiting, 2 completed, 3 other |
| Linked publications | 16 (5 Cochrane reviews, 5 clinical trial publications, 4 meta-analyses, 1 systematic review, 1 randomised controlled trial publication) |
| 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT02879513 | Trial of Adjuvant Chemotherapy in Breast Cancer Patients With Pathological Partial Response and Complete Response to Neoadjuvant Chemotherapy 2014 | status unknown | Phase 3 | 290 |
| NCT00191854 | Gemcitabine Combinations in Metastatic Breast Cancer (MBC), 1st Line 2005 | completed | Phase 2 | 147 |
| NCT00003269 | Amifostine Followed by High Dose Chemotherapy in Treating Patients With Hematologic Cancer or Solid Tumors 1998 | completed | Phase 2 | 20 |
| NCT07372079 | Neoadjuvant Therapy for Early Triple-Negative Breast Cancer: A Response-Guided Approach Using Iparomlimab and Tuvonralimab Injection in Combination With Chemotherapy 2026 | not yet recruiting | Phase 2 | 40 |
| NCT06746870 | A Phase II Clinical Study to Evaluate the Safety, Pharmacokinetic Profile, and Preliminary Efficacy of IMM2510 in Combination with Chemotherapy As First-line Treatment in Subjects with Non-small Cell Lung Cancer or Triple-negative Breast Cancer 2024 | not yet recruiting | Phase 2 | 148 |
| NCT04159818 | Immune Induction Strategies to Improve Response to Immune Checkpoint Blockade in Triple Negative Breast Cancer (TNBC) Patients 2020 | recruiting | Phase 2 | 52 |
| NCT02544243 | Vinorelbine/Gemcitabine Versus Vinorelbine/Cisplatin in Metastatic Breast Cancer 2015 | status unknown | Phase 2 | 200 |
| NCT03387085 | QUILT-3.067: NANT Triple Negative Breast Cancer (TNBC) Vaccine: Molecularly Informed Integrated Immunotherapy in Subjects With TNBC Who Have Progressed on or After Standard-of-care Therapy. 2018 | terminated | PHASE1, PHASE2 | 9 |
Published literature
- Clinical trial publication A phase II randomized trial of gemcitabine plus cisplatin (GP) versus gemcitabine plus carboplatin (GC) as the first-line treatment of patients with metastatic triple-negative breast cancerGong C, Zhao Y, Wang L et al. · ESMO open · 2026 · PMID 41861752
- Clinical trial publication Safety and preliminary efficacy of adding tocilizumab to cisplatin/docetaxel for the treatment of locally advanced triple-negative breast cancer patients: prospective phase 1/2 clinical trialAl-Tweigeri T, Tulbah A, Akhtar S et al. · Scientific reports · 2026 · PMID 41634354
- Clinical trial publication Prognostic value of visually and computationally assessed tumor-infiltrating lymphocytes in early-stage triple-negative breast cancer (TBCRC-030)Nader-Marta G, Chu X, Mukhopadhyay S et al. · Journal of the National Cancer Institute · 2026 · PMID 41075163
- Meta-analysis Integration Analysis of Bayesian and Machine Learning for Heterogeneity, Biomarkers, and Optimal Combination Regimens of Pucotenlimab in Solid TumorsHe Y, Gao C, Zhang S et al. · Cancer medicine · 2026 · PMID 42043855
- Clinical trial publication Application of Neoadjuvant Docetaxel plus Cisplatin in Early-Stage Triple-Negative Breast Cancer (HELEN-001): Results from a Phase II TrialJiao D, Qiao J, Sun X et al. · Clinical cancer research : an official journal of the American Association for Cancer Research · 2025 · PMID 40260648
- Cochrane review Efficacy and safety of platinum-based, anthracycline-free neoadjuvant chemotherapy for triple-negative breast cancer: a systematic review and meta-analysisDu Y, Huang L · Discover oncology · 2025 · PMID 40817946
- Meta-analysis Are hydrogels suitable for delivery of cisplatin to the microenvironment in breast cancer treatment: a meta-analysisIzadi Nazar AH, Safari Faramani R, Roushani Roudsari Y et al. · Therapeutic delivery · 2025 · PMID 41065771
- Clinical trial publication Intensive chemotherapy versus standard chemotherapy among patients with high risk, operable, triple negative breast cancer based on integrated mRNA-lncRNA signature (BCTOP-T-A01): randomised, multicentre, phase 3 trialHe M, Jiang YZ, Gong Y et al. · BMJ (Clinical research ed.) · 2024 · PMID 39442958
- Cochrane review Platinum dose in neoadjuvant therapy for triple-negative breast cancer: A systematic review and network meta-analysisPetrelli F, Ghidini A, Rea C et al. · Current problems in cancer · 2024 · PMID 38608530
- Cochrane review Efficacy and safety of first-line treatment for metastatic triple-negative breast cancer: A network meta-analysisShi M, Li Z, Shen G et al. · Cancer pathogenesis and therapy · 2024 · PMID 38601487
- 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
- Randomized controlled trial Metronomic chemotherapy plus anti-PD-1 in metastatic breast cancer: a Bayesian adaptive randomized phase 2 trialMo H, Yu Y, Sun X et al. · Nature medicine · 2024 · PMID 38969879
- Systematic review Reawakening the master switches in triple-negative breast cancer: A strategic blueprint for confronting metastasis and chemoresistance via microRNA-200/205: A systematic reviewAhmadi-Hadad A, de Queiroz PCC, Schettini F et al. · Critical reviews in oncology/hematology · 2024 · PMID 39306311
- Cochrane review 2023 updated MASCC/ESMO consensus recommendations: prevention of nausea and vomiting following high-emetic-risk antineoplastic agentsHerrstedt J, Celio L, Hesketh PJ et al. · Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2023 · PMID 38127246
- Cochrane review Platinum-based chemotherapy for early triple-negative breast cancerMason SR, Willson ML, Egger SJ et al. · The Cochrane database of systematic reviews · 2023 · PMID 37681577
- Meta-analysis The correlation of leukocyte-specific protein 1 (LSP1) rs3817198(T>C) polymorphism with breast cancer: A meta-analysisChen J, Xiao Q, Li X et al. · Medicine · 2022 · PMID 36397430
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 Cisplatin approved for Breast Cancer?
Cisplatin 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 Cisplatin in clinical trials for Breast Cancer?
ClinicalTrials.gov lists 8 registered trials linking Cisplatin to Breast Cancer: 1 is currently recruiting; 2 are active or not yet recruiting; 2 have completed; 3 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 3 (NCT02879513). It plans or enrolled 290 participants. Registration activity spans 1998 to 2026.
What does the evidence show for Cisplatin in Breast Cancer?
Cisplatin 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.