NCT06642428

Effect of Vitamin D Supplementation on the Efficacy and Adverse Effects of Neoadjuvant Therapy in Patients with Breast Cancer

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: Jiuda Zhao · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This randomized controlled Phase III trial was designed to evaluate the impact of supplemental vitamin D (VD) on the efficacy and side effects of neoadjuvant therapy in patients with breast cancer.

Detailed description

This is a parallel-group, open-label randomized controlled trial designed to investigate the effects of supplemental vitamin D (VD) on the outcomes and side effects of neoadjuvant therapy in patients with breast cancer. Both groups will receive standard neoadjuvant therapy on day 1 and for each subsequent cycle. Additionally, vitamin D2 will be randomly administered to both groups.Blood samples and imaging results will be collected and analyzed prior to the initiation of neoadjuvant therapy and after every two cycles. Key outcomes to be recorded include the pathological complete response rate (pCR), objective response rate (ORR), disease control rate (DCR), and grade III or higher adverse effects related to neoadjuvant therapy. The primary and secondary study findings, along with adverse events, will be thoroughly evaluated.

Conditions

• Vitamin D
• Neoadjuvant Therapy
• Breast Cancer
• Adverse Reaction
• Efficacy
• Chemotherapy

Interventions

Type	Name	Description
DRUG	Neoadjuvant therapy + vitamin D2	Before the start of treatment and every 3 weeks thereafter, participants will receive injections of vitamin D2 at a dosage of 10 mg until the completion of neoadjuvant therapy. They will undergo the standard neoadjuvant regimen, which includes the 10 mg injection of vitamin D2 per cycle during the therapy. The dosage of neoadjuvant drugs may be tailored based on the physician's clinical judgment.
DRUG	Neoadjuvant therapy	Participants will receive the standard neoadjuvant regimen during each cycle of neoadjuvant therapy. The dosage of the neoadjuvant drugs may be tailored based on the physician's clinical judgment.

Timeline

• Start date: 2024-10-18
• Primary completion: 2026-01-31
• Completion: 2026-04-30
• First posted: 2024-10-15
• Last updated: 2025-01-17

Locations

2 sites across 1 country: China