Summary
Gemcitabine 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ClinicalTrials.gov lists 8 registered trials linking Gemcitabine to Breast Cancer: 5 have completed; 3 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 2 (NCT02544243). The largest enrolment is 480 participants (NCT06481553). Registration activity spans 2005 to 2023. The literature layer holds 17 publications for this pair: 5 Cochrane reviews, 1 meta-analysis, 4 systematic reviews, 2 randomised controlled trial publications and 5 clinical trial publications. Publication years run from 2008 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 | 70.5 (trials 20.5, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 0 recruiting, 0 active / not yet recruiting, 5 completed, 3 other |
| Linked publications | 17 (5 Cochrane reviews, 5 clinical trial publications, 4 systematic reviews, 2 randomised controlled 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trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5).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 |
|---|---|---|---|---|
| NCT00662129 | Paclitaxel Albumin-Stabilized Nanoparticle Formulation, Gemcitabine, and Bevacizumab in Treating Patients With Metastatic Breast Cancer 2008 | completed | Phase 2 | 50 |
| NCT00191854 | Gemcitabine Combinations in Metastatic Breast Cancer (MBC), 1st Line 2005 | completed | Phase 2 | 147 |
| NCT04681911 | Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer 2020 | status unknown | Phase 2 | 71 |
| NCT02544243 | Vinorelbine/Gemcitabine Versus Vinorelbine/Cisplatin in Metastatic Breast Cancer 2015 | status unknown | Phase 2 | 200 |
| NCT01133912 | Preoperative Chemotherapy With Paclitaxel, Gemcitabine, and Lapatinib (Tykerb®) (PGT) 2009 | completed | Phase 1 | 13 |
| NCT02046421 | Carboplatin, Gemcitabine Hydrochloride, and Mifepristone in Treating Patients With Advanced Breast Cancer or Recurrent or Persistent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer 2013 | completed | Phase 1 | 31 |
| NCT02139358 | Phase I/IIa Trial of Gemcitabine Plus Trastuzumab and Pertuzumab in Previously Treated Metastatic HER2+ Breast Cancer 2014 | completed | PHASE1, PHASE2 | 15 |
| NCT06481553 | RWS of Paclitaxel Liposome Combined With Anti-HER-2 Monoclonal Antibody 2023 | status unknown | Not applicable | 480 |
Published literature
- Clinical trial publication A phase II randomized trial of gemcitabine plus cisplatin (GP) versus gemcitabine plus carboplatin (GC) as the first-line treatment of patients with metastatic triple-negative breast cancerGong C, Zhao Y, Wang L et al. · ESMO open · 2026 · PMID 41861752
- Clinical trial publication Datopotamab deruxtecan versus chemotherapy in previously treated inoperable/metastatic hormone receptor-positive, HER2-negative breast cancer: final overall survival analysis of the phase III TROPION-Breast01 studyPistilli B, Jhaveri K, Im SA et al. · Annals of oncology : official journal of the European Society for Medical Oncology · 2026 · PMID 41448362
- Meta-analysis Integration Analysis of Bayesian and Machine Learning for Heterogeneity, Biomarkers, and Optimal Combination Regimens of Pucotenlimab in Solid TumorsHe Y, Gao C, Zhang S et al. · Cancer medicine · 2026 · PMID 42043855
- Clinical trial publication Adoptive cell transfer therapy with ex vivo primed peripheral lymphocytes in combination with chemotherapy in locally advanced or metastatic triple-negative breast cancer: the ImmunoBreast phase Ib clinical trialGammelgaard OL, Ehmsen S, Jylling AMB et al. · Journal for immunotherapy of cancer · 2025 · PMID 41344991
- Clinical trial publication Sacituzumab Govitecan in Untreated, Advanced Triple-Negative Breast CancerCortés J, Punie K, Barrios C et al. · The New England journal of medicine · 2025 · PMID 41124233
- Clinical trial publication Carboplatin, gemcitabine, and mifepristone for advanced breast and recurrent/persistent epithelial ovarian cancerStringer-Reasor EM, Saha P, Kocherginsky M et al. · Breast cancer research and treatment · 2025 · PMID 40779028
- Randomized controlled trial Immunomodulatory gene networks predict treatment response and survival to de-escalated, anthracycline-free neoadjuvant chemotherapy in triple-negative breast cancer in the WSG-ADAPT-TN trialKorbie D, Stirzaker C, Gluz O et al. · Molecular cancer · 2025 · PMID 40140821
- Randomized controlled trial Genetic Alterations, Therapy Response, and Survival Among Patients With Triple-Negative Breast Cancer: A Secondary Analysis of a Randomized Clinical TrialRichters L, Gluz O, Weber-Lassalle N et al. · JAMA network open · 2025 · PMID 40009381
- Cochrane review Different Chemotherapy Regimens and Pathologic Complete Response in Triple-Negative Breast Cancer: An Updated Network Meta-Analysis of Phase 3 TrialsPetrelli F, Tomasello G, Parati MC et al. · Medicina (Kaunas, Lithuania) · 2024 · PMID 38399628
- Cochrane review Radiation recall dermatitis: A review of the literatureBhangoo RS, Cheng TW, Petersen MM et al. · Seminars in oncology · 2022 · PMID 35585004
- Cochrane review Network meta-analysis of eribulin versus other chemotherapies used as second- or later-line treatment in locally advanced or metastatic breast cancerZhao Q, Hughes R, Neupane B et al. · BMC cancer · 2021 · PMID 34193107
- Cochrane review The Impact of Platinum-Containing Chemotherapies in Advanced Triple-Negative Breast Cancer: Meta-Analytical Approach to Evaluating Its Efficacy and SafetyYang R, Shi YY, Han XH et al. · Oncology research and treatment · 2021 · PMID 33975311
- Cochrane review Comparative Effectiveness of Taxane-Containing Regimens for Treatment of HER2-Negative Metastatic Breast Cancer: A Network Meta-analysisDong L, Zhu LN, Xie BJ et al. · Pharmacotherapy · 2019 · PMID 31692005
- Systematic review Efficacy and safety of palliative chemotherapy for patients with advanced breast cancer pretreated with anthracyclines and taxanes: a systematic reviewOostendorp LJ, Stalmeier PF, Donders AR et al. · The Lancet. Oncology · 2011 · PMID 21621462
- Systematic review The clinical efficacy of cytotoxic agents in locally advanced or metastatic breast cancer patients pretreated with an anthracycline and a taxane: a systematic reviewJassem J, Carroll C, Ward SE et al. · European journal of cancer (Oxford, England : 1990) · 2009 · PMID 19615886
- Systematic review Multiple-treatments meta-analysis of chemotherapy and targeted therapies in advanced breast cancerMauri D, Polyzos NP, Salanti G et al. · Journal of the National Cancer Institute · 2008 · PMID 19066278
- Systematic review Time to full publication of studies of anti-cancer medicines for breast cancer and the potential for publication bias: a short systematic reviewTakeda A, Loveman E, Harris P et al. · Health technology assessment (Winchester, England) · 2008 · PMID 18831948
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 Gemcitabine approved for Breast Cancer?
Gemcitabine 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 Gemcitabine in clinical trials for Breast Cancer?
ClinicalTrials.gov lists 8 registered trials linking Gemcitabine to Breast Cancer: 5 have completed; 3 are terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 2 (NCT02544243). The largest enrolment is 480 participants (NCT06481553). Registration activity spans 2005 to 2023.
What does the evidence show for Gemcitabine in Breast Cancer?
Gemcitabine 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.