Disease × agent evidence record

Vinorelbine for Breast Cancer: evidence, trials and status

Vinorelbine 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.

8 registered trials 1 recruiting 16 publications Evidence tier A · Strong Score 73.0
Research Tracker › Pairs › Breast Cancer › Vinorelbine
Research map, not treatment advice. This page aggregates registry and literature records. It does not evaluate efficacy, dosing or safety for any individual. Discuss any treatment decision with a qualified clinician.

Summary

Vinorelbine 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 Vinorelbine to Breast Cancer: 1 is currently recruiting; 1 is active or not yet recruiting; 4 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 3 (NCT07556848). It plans or enrolled 356 participants. Registration activity spans 1999 to 2026. The literature layer holds 16 publications for this pair: 5 Cochrane reviews, 3 meta-analyses, 1 systematic review, 2 randomised controlled trial publications and 5 clinical trial publications. Publication years run from 2011 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.

Open in Repurposing ExplorerBreast Cancer hubBreast Cancer biomarkers & interventions

Evidence table

Evidence tierA · Strong
Evidence score73.0 (trials 23.0, literature 30.0, tier 15, approved bonus 5.0)
Registered trials8 total: 1 recruiting, 1 active / not yet recruiting, 4 completed, 2 other
Linked publications16 (5 Cochrane reviews, 5 clinical trial publications, 3 meta-analyses, 2 randomised controlled trial publications, 1 systematic review)
Agent typeDrug (Small molecule)
Development stage (any indication)Approved
Mechanism / classNot recorded
Data sourcesDGIdb
Linked via biomarker / targetBRCA1
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 IDTitleStatusPhaseEnrolment
NCT07556848A Study of 9MW2821 Versus Chemotherapy in Participants With Previously Treated Locally Advanced or Metastatic Triple-Negative Breast Cancer
2026
not yet recruitingPhase 3356
NCT03321981MCLA-128 With Trastuzumab/Chemotherapy in HER2+ and With Endocrine Therapy in ER+ and Low HER2 Breast Cancer.
2018
completedPhase 2105
NCT04681911Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer
2020
status unknownPhase 271
NCT02544243Vinorelbine/Gemcitabine Versus Vinorelbine/Cisplatin in Metastatic Breast Cancer
2015
status unknownPhase 2200
NCT00724386Concomitant Chemoradiotherapy With Weekly Paclitaxel and Vinorelbine and Granulocyte Colony Stimulating Factor (GCSF) Support in Patients With Advanced Breast Cancer
1999
completedPhase 126
NCT00001944Vinorelbine and XR9576 to Treat Cancer
1999
completedPhase 130
NCT00912275Lapatinib in Combination With Oral Vinorelbine for Metastatic Breast Cancer
2008
completedPHASE1, PHASE246
NCT05856383Efficacy and Safety of Inetetamab Combined With Pyrotinib and Vinorelbine in ABC
2022
recruitingNot applicable100

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Published literature

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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 Vinorelbine approved for Breast Cancer?

Vinorelbine 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 Vinorelbine in clinical trials for Breast Cancer?

ClinicalTrials.gov lists 8 registered trials linking Vinorelbine to Breast Cancer: 1 is currently recruiting; 1 is active or not yet recruiting; 4 have completed; 2 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 3 (NCT07556848). It plans or enrolled 356 participants. Registration activity spans 1999 to 2026.

What does the evidence show for Vinorelbine in Breast Cancer?

Vinorelbine 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

Open Source Medicine Foundation. Vinorelbine for Breast Cancer: evidence, trials and status. OSMF Research Tracker. Updated 2026-07-05. https://research.opensourcemed.info/pairs/breast-cancer/vinorelbine.html

Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.

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This is a research map, not treatment advice. Evidence tiers and scores summarise what has been studied, not whether a treatment works or is safe for you.