Summary
Riboflavin 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 ClinicalTrials.gov lists 2 registered trials linking Riboflavin to Breast Cancer: 1 has completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT04669119). The largest enrolment is 197 participants (NCT00204490). Registration activity spans 2004 to 2020. The literature layer holds 6 publications for this pair: 1 meta-analysis and 5 clinical trial publications. Publication years run from 2008 to 2024. 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 | 40.5 (trials 6.5, literature 14.0, tier 15, approved bonus 5.0) |
| Registered trials | 2 total: 0 recruiting, 0 active / not yet recruiting, 1 completed, 1 other |
| Linked publications | 6 (5 clinical trial publications, 1 meta-analysis) |
| 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT04669119 | Effects of Bromelain and Boswellia Serrata Casperome With Centella Asiatica and Vitamins on Edema, Paresthesia and Postoperative Pain After Quadrantectomy With or Without Sentinel Lymph Node Biopsy. 2020 | status unknown | Phase 4 | 120 |
| NCT00204490 | Soy Isoflavones and Breast Cancer Risk Reduction 2004 | completed | Phase 2 | 197 |
Published literature
- Clinical trial publication Ticagrelor modestly raises plasma riboflavin concentration in humans and inhibits riboflavin transport by BCRP and MRP4Deng F, Hämäläinen K, Lehtisalo M et al. · Clinical pharmacology and therapeutics · 2024 · PMID 39039844
- Clinical trial publication A Pilot Study To Assess the Suitability of Riboflavin As a Surrogate Marker of Breast Cancer Resistance Protein in Healthy ParticipantsShen H, Huo R, Zhang Y et al. · The Journal of pharmacology and experimental therapeutics · 2024 · PMID 38296646
- Meta-analysis Association Between One-carbon Metabolism-related Vitamins and Risk of Breast Cancer: A Systematic Review and Meta-analysis of Prospective StudiesZeng J, Gu Y, Fu H et al. · Clinical breast cancer · 2020 · PMID 32241696
- Clinical trial publication Dietary intake of selected B vitamins in relation to risk of major cancers in womenKabat GC, Miller AB, Jain M et al. · British journal of cancer · 2008 · PMID 18665162
- Clinical trial publication Anti-angiogenic potential of CoenzymeQ10, riboflavin and niacin in breast cancer patients undergoing tamoxifen therapyPremkumar VG, Yuvaraj S, Sathish S et al. · Vascular pharmacology · 2008 · PMID 18407793
- Clinical trial publication Co-enzyme Q10, riboflavin and niacin supplementation on alteration of DNA repair enzyme and DNA methylation in breast cancer patients undergoing tamoxifen therapyPremkumar VG, Yuvaraj S, Shanthi P et al. · The British journal of nutrition · 2008 · PMID 18377693
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 Riboflavin approved for Breast Cancer?
Riboflavin 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 Riboflavin in clinical trials for Breast Cancer?
ClinicalTrials.gov lists 2 registered trials linking Riboflavin to Breast Cancer: 1 has completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT04669119). The largest enrolment is 197 participants (NCT00204490). Registration activity spans 2004 to 2020.
What does the evidence show for Riboflavin in Breast Cancer?
Riboflavin 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.