Fasting-Mimicking Diet as an Adjunct to Neoadjuvant Chemotherapy for Hormone-Receptor-Positive Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fasting-mimicking diet (FMD) Group.
- Who it may be relevant to
- Registry conditions: Fasting-Mimicking Diet, Breast Cancer, Neoadjuvant Chemotherapy. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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%).
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.
Primary outcome measures
- Pathological complete response (pCR) rate [Time frame: lmmediately after surgery]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Guangdong Provincial People's Hospital — Guangzhou
Identifiers
NCT: NCT07077018 · NeoFMD