Summary
Mitomycin 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 4 registered trials linking Mitomycin to Breast Cancer: 1 is active or not yet recruiting; 2 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 3 (NCT00003893). It plans or enrolled 2250 participants. Registration activity spans 1998 to 2014. The literature layer holds 8 publications for this pair: 1 systematic review, 2 randomised controlled trial publications and 5 clinical trial publications. Publication years run from 2000 to 2017. 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 | 54.0 (trials 15.0, literature 19.0, tier 15, approved bonus 5.0) |
| Registered trials | 4 total: 0 recruiting, 1 active / not yet recruiting, 2 completed, 1 other |
| Linked publications | 8 (5 clinical trial publications, 2 randomised controlled trial publications, 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT01091168 | Trial of Vinflunine Versus Alkylating Agent in Metastatic Breast Cancer 2009 | completed | Phase 3 | 594 |
| NCT00003893 | Adjuvant Chemotherapy Plus Radiation Therapy in Treating Women With Early-Stage Breast Cancer 1998 | completed | Phase 3 | 2,250 |
| NCT02299999 | SAFIR02_Breast - Efficacy of Genome Analysis as a Therapeutic Decision Tool for Patients With Metastatic Breast Cancer 2014 | active, not recruiting | Phase 2 | 1,460 |
| NCT01196455 | Capecitabine and Mitomycin C in Treatment of Patients With Metastatic Breast Cancer 2006 | status unknown | Phase 2 | 39 |
Published literature
- Clinical trial publication Role of Mitomycin C in Preventing Capsular Contracture in Implant-Based Reconstructive Breast Surgery: A Randomized Controlled TrialNava MB, Rocco N, Catanuto G et al. · Plastic and reconstructive surgery · 2017 · PMID 28350652
- Clinical trial publication Mitomycin C in combination with vinorelbine in anthracycline- and/or taxane-pretreated patients with metastatic breast cancerSchippert C, Warm M, Blohmer JU et al. · Onkologie · 2012 · PMID 23007147
- Clinical trial publication Low expression levels of ATM may substitute for CHEK2 /TP53 mutations predicting resistance towards anthracycline and mitomycin chemotherapy in breast cancerKnappskog S, Chrisanthar R, Løkkevik E et al. · Breast cancer research : BCR · 2012 · PMID 22420423
- Clinical trial publication Combination of capecitabine and mitomycin C as first-line treatment in patients with metastatic breast cancerVrdoljak E, Boban M, Omrcen T et al. · Neoplasma · 2011 · PMID 21275468
- Clinical trial publication Transarterial chemoembolization (TACE) with mitomycin C and gemcitabine for liver metastases in breast cancerVogl TJ, Naguib NN, Nour-Eldin NE et al. · European radiology · 2010 · PMID 19657653
- Randomized controlled trial Randomized phase II trial on mitomycin-C/cisplatin +/- KLT in heavily pretreated advanced breast cancerGuo HY, Cai Y, Yang XM et al. · The American journal of Chinese medicine · 2008 · PMID 18711764
- Randomized controlled trial Good clinical response of breast cancers to neoadjuvant chemoendocrine therapy is associated with improved overall survivalCleator SJ, Makris A, Ashley SE et al. · Annals of oncology : official journal of the European Society for Medical Oncology · 2005 · PMID 15668282
- Systematic review A rapid and systematic review of the effectiveness and cost-effectiveness of the taxanes used in the treatment of advanced breast and ovarian cancerLister-Sharp D, McDonagh MS, Khan KS et al. · Health technology assessment (Winchester, England) · 2000 · PMID 11074389
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 Mitomycin approved for Breast Cancer?
Mitomycin 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 Mitomycin in clinical trials for Breast Cancer?
ClinicalTrials.gov lists 4 registered trials linking Mitomycin to Breast Cancer: 1 is active or not yet recruiting; 2 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 3 (NCT00003893). It plans or enrolled 2250 participants. Registration activity spans 1998 to 2014.
What does the evidence show for Mitomycin in Breast Cancer?
Mitomycin 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.