Vitamin D Supplementation During Neoadjuvant Chemotherapy for Breast Cancer Improves Pathological Complete Response: A Prospective Randomized Clinical Trial

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#humans #female #breast-neoplasms #neoadjuvant-therapy #prospective-studies

Vitamin D Supplementation During Neoadjuvant Chemotherapy for Breast Cancer Improves Pathological Complete Response: A Prospective Randomized Clinical Trial

Özkurt et al., 2025 | World J Surg | Rct

Citation

Özkurt Enver, Ordu Cetin, ... Ozmen Vahit. Vitamin D Supplementation During Neoadjuvant Chemotherapy for Breast Cancer Improves Pathological Complete Response: A Prospective Randomized Clinical Trial. World J Surg. 2025-Jun;49(6):1396-1405. doi:10.1002/wjs.12587

Abstract

INTRODUCTION: Achieving a pCR serves as a biomarker indicating enhanced overall survival for breast cancer patients undergoing NST. Vitamin D enhances the antitumor effect of chemotherapeutics as demonstrated in cancer cells and animal models. In this prospective randomized clinical study, we aim to investigate the effect of oral vitamin D supplementation during neoadjuvant systemic therapy (NST) on pathologic complete response (pCR). METHODS: Between June 2019 and June 2023, an oral form of 50,000 IU vitamin D3 (cholecalciferol) replacement was administered once a week during NST for the study group. RESULTS: There were 114 (50.2%) cases in the study group and 113 (49.8%) in the control group (totally 227 cases). Factors that positively influenced pCR were higher clinical T stage, higher AJCC clinical stage, Estrogen receptor negativity, progesterone receptor negativity, human epidermal growth factor receptor 2 positivity, high Ki-67 expression (≥ 20%), hormone negative molecular subtypes, and vitamin D intake in univariate analysis. In the multivariate analysis, factors significantly affecting pCR were vitamin D intake (OR: 2.33, 95% CI 1.20-4.53; p = 0.013), hormone receptor negativity (OR: 2.22, 95% CI 1.11-4.43; p = 0.024), and Ki-67 ≥ 20% (OR: 3.27, 95% CI 1.03-10.34; p = 0.044). CONCLUSIONS: This is the first and only study to compare the effect of oral vitamin D supplementation on pCR during NST. Vitamin D supplementation during NST has a significant effect on pCR in breast cancer patients. Although this effect is not significant for axillary pCR, there is an almost significant correlation. TRIAL REGISTRATION: ClinicalTrials.gov (Identifier: NCT03986268).

Key Findings

There were 114 (50.2%) cases in the study group and 113 (49.8%) in the control group (totally 227 cases). Factors that positively influenced pCR were higher clinical T stage, higher AJCC clinical stage, Estrogen receptor negativity, progesterone receptor negativity, human epidermal growth factor receptor 2 positivity, high Ki-67 expression (≥ 20%), hormone negative molecular subtypes, and vitamin D intake in univariate analysis. In the multivariate analysis, factors significantly affecting pCR w

Outcomes Measured

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Population

Field Value
Population See abstract
Sample Size See abstract
Age Range See abstract
Condition See abstract

MeSH Terms

  • Humans
  • Female
  • Breast Neoplasms
  • Neoadjuvant Therapy
  • Prospective Studies
  • Middle Aged
  • Dietary Supplements
  • Adult
  • Vitamin D
  • Aged
  • Chemotherapy, Adjuvant
  • Vitamins
  • Treatment Outcome

Evidence Classification

  • Level: Rct
  • Publication Types: Journal Article, Randomized Controlled Trial
  • Vertical: vitamin-d-cancer

Provenance

Source extracted via PubMed E-utilities API on 2026-04-09