NCT07077018

Fasting-Mimicking Diet as an Adjunct to Neoadjuvant Chemotherapy for Hormone-Receptor-Positive Breast Cancer

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: Guangdong Provincial People's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a phase II, Single-Arm Clinical Study evaluating the efficacy and safety of a fasting-mimicking diet (FMD) combined with neoadjuvant chemotherapy in patients with ER-positive, HER2-negative breast cancer. Participants will be assigned to Intervention group: 4-day FMD cycles (827± 100kcal/day on Day 1, 637± 100kcal/day on Days 2-4) synchronized with T-EC chemotherapy. The primary endpoint is pathological complete response (pCR) rate. Secondary endpoints include metabolic changes, immune markers, quality of life, and safety (CTCAE v5.0). A total patients will be enrolled to detect a 15% pCR improvement (25% vs. 10%, α=0.05, power=80%).

Conditions

• Fasting-Mimicking Diet
• Breast Cancer
• Neoadjuvant Chemotherapy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Fasting-mimicking diet (FMD) Group	The FMD will consist of a triweekly 4-day regimen of a plant-based, calorie-restricted (827± 100 kcal on day 1；637 ± 100 kcal on days 2-4), low-carbohydrate, low-protein diet. The FMD will be repeated up to a maximum of eight consecutive cycles. Participants receive the FMD for 2 days prior to and on the day and one day after each cycle of chemotherapy.

Timeline

• Start date: 2025-07-12
• Primary completion: 2026-12-30
• Completion: 2026-12-30
• First posted: 2025-07-22
• Last updated: 2025-07-22

Locations

1 site across 1 country: China