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Introduction <p>Metformin has been explored as an anticancer agent in breast cancer, but randomized trial evidence remains inconsistent. This updated review evaluated neoadjuvant metformin’s effect on response outcomes in non-diabetic patients with non-metastatic breast cancer.</p> Methods <p>A systematic review and meta-analysis were conducted (PROSPERO: CRD420251039988). PubMed, Web of Science, ClinicalTrials.gov, and ICTRP were searched until April 2025. Randomized-controlled trials comparing neoadjuvant metformin plus standard of care (SOC) versus SOC alone in non-diabetic patients with stage I–III breast cancer were included. Primary outcomes were pathological and clinical complete response (pCR/cCR); secondary outcomes were overall response and pathological response (oRR/oPR), with breast-conserving surgery (BCS) evaluated as a tertiary outcome. Risk ratios (RRs) with 95% confidence intervals (CIs) were pooled using random-effects models. Post-hoc meta-regression and subgroup analyses were also performed.</p> Results <p>Fifteen trials, including 1,125 patients, were analyzed. Metformin was not significantly associated with improvements in pCR (RR 1.17, 95% CI 0.97–1.40), cCR (RR 1.53, 95% CI 0.87–2.70), oRR (RR 1.23, 95% CI 0.89–1.69), oPR (RR 1.21, 95% CI 0.96–1.52), or BCS (RR 1.10, 95% CI 0.90–1.35). Exploratory subgroup analysis suggested increased pCR in HER2 + disease (RR 1.22, 95% CI 1.01–1.49). Higher study-level body mass index (BMI) was associated with improved response outcomes.</p> Conclusion <p>Neoadjuvant metformin did not significantly improve treatment response in non-diabetic patients with non-metastatic breast cancer, though these findings are limited by low-to-very low certainty of evidence. Exploratory subgroup analyses suggested potential benefits in HER2 + disease and in studies with higher BMI, warranting further investigation.</p>

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Neoadjuvant metformin on clinical and pathological response in non-diabetic patients with non-metastatic breast cancer: an updated systematic review and meta-analysis

  • 期刊论文

  • 发表日期：

    2026年7月3日

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  • Diego Arriaga‐Izabal,
  • Francisco Morales‐Lazcano,
  • Uriel A. Angulo-Zamudio,
  • Adrian Canizalez-Román,
  • Nidia León-Sicairos

摘要

Introduction

Metformin has been explored as an anticancer agent in breast cancer, but randomized trial evidence remains inconsistent. This updated review evaluated neoadjuvant metformin’s effect on response outcomes in non-diabetic patients with non-metastatic breast cancer.

Methods

A systematic review and meta-analysis were conducted (PROSPERO: CRD420251039988). PubMed, Web of Science, ClinicalTrials.gov, and ICTRP were searched until April 2025. Randomized-controlled trials comparing neoadjuvant metformin plus standard of care (SOC) versus SOC alone in non-diabetic patients with stage I–III breast cancer were included. Primary outcomes were pathological and clinical complete response (pCR/cCR); secondary outcomes were overall response and pathological response (oRR/oPR), with breast-conserving surgery (BCS) evaluated as a tertiary outcome. Risk ratios (RRs) with 95% confidence intervals (CIs) were pooled using random-effects models. Post-hoc meta-regression and subgroup analyses were also performed.

Results

Fifteen trials, including 1,125 patients, were analyzed. Metformin was not significantly associated with improvements in pCR (RR 1.17, 95% CI 0.97–1.40), cCR (RR 1.53, 95% CI 0.87–2.70), oRR (RR 1.23, 95% CI 0.89–1.69), oPR (RR 1.21, 95% CI 0.96–1.52), or BCS (RR 1.10, 95% CI 0.90–1.35). Exploratory subgroup analysis suggested increased pCR in HER2 + disease (RR 1.22, 95% CI 1.01–1.49). Higher study-level body mass index (BMI) was associated with improved response outcomes.

Conclusion

Neoadjuvant metformin did not significantly improve treatment response in non-diabetic patients with non-metastatic breast cancer, though these findings are limited by low-to-very low certainty of evidence. Exploratory subgroup analyses suggested potential benefits in HER2 + disease and in studies with higher BMI, warranting further investigation.