Summary
Epirubicin 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 Epirubicin to Breast Cancer: 1 is currently recruiting; 1 is active or not yet recruiting; 3 have completed; 3 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 3 (NCT00003577). It plans or enrolled 2000 participants. Registration activity spans 1996 to 2023. The literature layer holds 14 publications for this pair: 5 Cochrane reviews, 2 meta-analyses, 1 systematic review, 1 randomised controlled trial publication and 5 clinical trial publications. Publication years run from 2021 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 | 76.5 (trials 26.5, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 1 recruiting, 1 active / not yet recruiting, 3 completed, 3 other |
| Linked publications | 14 (5 Cochrane reviews, 5 clinical trial publications, 2 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 | Open Targets, ChEMBL |
| Linked via biomarker / target | AKT1 |
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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT01996267 | Neoadjuvant Chemotherapy in HER2 Positive Breast Cancer, TRAIN-2 2013 | active, not recruiting | Phase 3 | 437 |
| NCT00003577 | Combination Chemotherapy With or Without Epirubicin in Treating Women With Stage I or Stage II Breast Cancer 1996 | completed | Phase 3 | 2,000 |
| NCT00003012 | Combination Chemotherapy Following Surgery in Treating Women With Early Stage Breast Cancer 1996 | completed | Phase 3 | 1,000 |
| NCT05909332 | Study of Antivascular Therapy Combined With Chemotherapy Versus Chemotherapy in Adjuvant Therapy of TNBC-BLIS Patients (BCTOP-T-A03) 2023 | recruiting | Phase 3 | 764 |
| NCT01036087 | Panitumumab, Nab-paclitaxel and Carboplatin for HER2 Negative Inflammatory Breast Cancer 2010 | completed | Phase 2 | 47 |
| NCT02115152 | Neoadjuvant Trial of Capecitabine for Axillary Lymph Node Positive Operable Breast Cancer 2014 | status unknown | Phase 2 | 100 |
| NCT02067416 | PREDATOR: Neoadjuvant Gene Prediction for Breast Cancer 2012 | withdrawn | Phase 2 | — |
| NCT01159236 | Molecular Triaging of Newly Diagnosed Breast Cancer 2010 | withdrawn | Not applicable | — |
Published literature
- Clinical trial publication Pragmatic Clinical Trial Assessing Response to Neoadjuvant Docetaxel and Trastuzumab in Nigerian Women With Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer (ARETTA)Ntekim A, Popoola A, Sowunmi A et al. · JCO global oncology · 2026 · PMID 42214048
- Clinical trial publication Durvalumab in Combination With Neoadjuvant Chemotherapy in Early Triple-Negative Breast Cancer: Long-Term Analysis From the GeparNuevo TrialLoibl S, Untch M, Huober J et al. · Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2026 · PMID 42008768
- Clinical trial publication Surgical Outcomes After Neoadjuvant Pembrolizumab Plus Chemotherapy for Triple-Negative Breast Cancer: Results from the Randomized, Placebo-Controlled Phase 3 KEYNOTE-522 StudyKuemmel S, Fasching PA, Schmid P et al. · Annals of surgical oncology · 2026 · PMID 41739398
- Clinical trial publication Adjuvant Epirubicin Plus Cyclophosphamide Followed by Taxanes With or Without Carboplatin in Early-Stage Triple-Negative Breast Cancer (RJBC 1501): A Randomized Phase III TrialChen X, Huang J, Shi H et al. · Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2026 · PMID 41365333
- Clinical trial publication Effect of adjuvant carboplatin intensified chemotherapy versus standard chemotherapy on survival in women with high risk, early stage, triple negative breast cancer (CITRINE): randomised, open label phase 3 trialLiu Y, Gong Y, Zhu XZ et al. · BMJ (Clinical research ed.) · 2025 · PMID 41436191
- Cochrane review Efficacy and cardiovascular safety of liposomal doxorubicin: a systematic review and meta-analysis of randomized trialsCavalli GD, Lopez-Lopez JP, Carandang FC et al. · Cardio-oncology (London, England) · 2025 · PMID 41084073
- Cochrane review Comparison of the efficacy and safety of docetaxel plus capecitabine versus docetaxel plus epirubicin for human epidermal growth factor 2 -negative breast cancer: a meta-analysisWu J, Wang Z, Fu Y · BMC women's health · 2025 · PMID 40055784
- Randomized controlled trial Long-term outcome data for patients with hormone receptor-positive early breast cancer participating in the WSG PlanB trial after preselection by gene expression analysis: 10-year survival results from the WSG PlanB registryNitz U, Graeser M, Gluz O et al. · ESMO open · 2025 · PMID 41313970
- Systematic review [Effect of taste perception on nutritional status in patients with breast cancer: a systematic review]Rivas-Acosta H, Vedrenne-Gutiérrez F, Ramírez Monroy MF et al. · Nutricion hospitalaria · 2025 · PMID 40504002
- Cochrane review The Omission of Anthracycline Chemotherapy in Women with Early HER2-Negative Breast Cancer-A Systematic Review and Meta-AnalysisGiffoni de Mello Morais Mata D, Rush MB, Smith-Uffen M et al. · Current oncology (Toronto, Ont.) · 2024 · PMID 39195318
- Cochrane review Concurrent epirubicin and trastuzumab use increases complete pathological response rate without additional cardiotoxicity in patients with human epidermal growth factor receptor 2-positive early breast cancer: A meta-regression analysisYang MH, Huang CS, Chang DY et al. · Cancer medicine · 2024 · PMID 39046067
- Cochrane review Effects of Integrated Chinese Traditional Medicine and Conventional Western Medicine on the Quality of Life of Breast Cancer Patients: A Systematic Review and Meta-AnalysisBai X, Ta N, Gong GH et al. · Evidence-based complementary and alternative medicine : eCAM · 2022 · PMID 35035500
- Meta-analysis Sequential vs concurrent adjuvant chemotherapy of anthracycline and taxane for operable breast cancerChen W, Tu Q, Shen Y et al. · World journal of surgical oncology · 2021 · PMID 33602236
- Meta-analysis Pharmacological interventions for preventing anthracycline-induced clinical and subclinical cardiotoxicity: A network meta-analysis of metastatic breast cancerGhasemi K, Vaseghi G, Mansourian M · Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners · 2021 · PMID 33081570
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 Open Targets and ChEMBL, in this case via the biomarker or target AKT1. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Epirubicin approved for Breast Cancer?
Epirubicin 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 Epirubicin in clinical trials for Breast Cancer?
ClinicalTrials.gov lists 8 registered trials linking Epirubicin to Breast Cancer: 1 is currently recruiting; 1 is active or not yet recruiting; 3 have completed; 3 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 3 (NCT00003577). It plans or enrolled 2000 participants. Registration activity spans 1996 to 2023.
What does the evidence show for Epirubicin in Breast Cancer?
Epirubicin 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 Open Targets and ChEMBL, in this case via the biomarker or target AKT1. 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.