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

Not Applicable

Not yet recruiting

• Conditions: Fasting-Mimicking Diet; Neoadjuvant Chemotherapy; Breast Cancer

• Registration Number: NCT07077018
• Lead Sponsor: Guangdong Provincial People's Hospital

Brief 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%).

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-11
• Study Start: 2025-07-12
• Study First Submitted QC: 2025-07-20
• Last Update Submitted: 2025-07-20
• Study First Posted: 2025-07-22
• Last Update Posted: 2025-07-22
• Primary Completion: 2026-12-30
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Histologically confirmed ER-positive , HER2-negative invasive ductal carcinoma meeting at least one of the following:1)T1c-T2 N1 with histological grade 2 (ER 1-10%) or grade 3. 2)N2-N3 or grade 3 and/or Ki67 ≥40%. 3)T3-T4
• Age 18-75 years at enrollment
• Body mass index (BMI) ≥18.5 kg/m²
• Adequate hematological function:1）White blood cell count>3.0×10⁹/L.2)Absolute neutrophil count ≥1.5×10⁹/L.3)Platelets ≥100×10⁹/L.
• Adequate organ function:1）Total bilirubin ≤1.5 × upper limit of normal (ULN).2）ALT/AST ≤2.5 × ULN. 3）Alkaline phosphatase ≤5 × ULN.4）Creatinine clearance ≥50 mL/min-1)
• ECOG performance status 0-2
• Willing and able to provide written informed consent

Exclusion Criteria

• Prior history of any malignancy (including contralateral breast cancer)
• Received any prior neoadjuvant chemotherapy cycle for current diagnosis
• Uncontrolled endocrine disorders:1)Diabetes mellitus requiring insulin or oral hypoglycemics.2)Hyper/hypothyroidism requiring medication
• Active autoimmune disease requiring systemic immunosuppressants
• Current use of antipsychotic medications
• Known hypersensitivity to FMD components (e.g., soy protein, milk protein, nuts)
• Pregnancy or lactation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Pathological complete response (pCR) rate	lmmediately after surgery	The primary study endpoint of this trial was pCR, as defined as the absence of residual invasive disease on evaluation of surgical breast specimen and surgically-resected lymph nodes (i.e. ypT0/Tis ypN0）

Trial Locations

Locations (1)

Guangdong Provincial People's Hospital; 🇨🇳 Guangzhou, China