Summary
Daunorubicin Hydrochloride 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 Daunorubicin Hydrochloride to Breast Cancer: 1 is active or not yet recruiting; 3 have completed; 4 are terminated, withdrawn, suspended or of unknown status.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 2018. No published literature item is linked to Daunorubicin Hydrochloride and Breast Cancer in the OSMF database yet, so the record rests on registry entries alone. Registry entries describe intent to study, not outcomes.
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 | 40.0 (trials 20.0, literature 0.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 0 recruiting, 1 active / not yet recruiting, 3 completed, 4 other |
| Linked publications | 0 |
| 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT00003577 | Combination Chemotherapy With or Without Epirubicin in Treating Women With Stage I or Stage II Breast Cancer 1996 | completed | Phase 3 | 2,000 |
| NCT00944047 | Evaluate Trastuzumab Plus Standard Chemotherapy Given Before Surgery in Breast Cancer Patients With Low HER 2 Expression 2009 | completed | Phase 2 | 32 |
| NCT01036087 | Panitumumab, Nab-paclitaxel and Carboplatin for HER2 Negative Inflammatory Breast Cancer 2010 | completed | Phase 2 | 47 |
| NCT00574236 | Phase II Trial of Bortezomib and Doxorubicin in Metastatic Breast Cancer 2006 | terminated | Phase 2 | 4 |
| 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 | — |
| NCT06190600 | Supervised Physical Activity in Young Women With Early Breast Cancer During Neoadjuvant Chemotherpy 2018 | active, not recruiting | Not applicable | 40 |
| NCT01697293 | PTX-200, Paclitaxel, Doxorubicin Hydrochloride, and Cyclophosphamide in Treating Patients With Stage IIB-IV Breast Cancer 2012 | terminated | PHASE1, PHASE2 | 34 |
Published literature
No publication is linked to this pair yet.
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 Daunorubicin Hydrochloride approved for Breast Cancer?
Daunorubicin Hydrochloride 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 Daunorubicin Hydrochloride in clinical trials for Breast Cancer?
ClinicalTrials.gov lists 8 registered trials linking Daunorubicin Hydrochloride to Breast Cancer: 1 is active or not yet recruiting; 3 have completed; 4 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 2018.
What does the evidence show for Daunorubicin Hydrochloride in Breast Cancer?
Daunorubicin Hydrochloride has 3 completed registered trials for Breast Cancer but no linked publication, which usually means results are unpublished, pending, or not yet matched to this record. 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.