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

NCT07077018 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2025-07-22

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Guangdong Provincial People's Hospital

    lead OTHER

Principal Investigators

  • Kun Wang · Guangdong Provincial People's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-12
Primary Completion
2026-12-30
Completion
2026-12-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07077018 on ClinicalTrials.gov