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%).
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.
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
Single group
Fasting-mimicking diet (FMD) Group
Dietary supplementThe 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.
Pathological complete response (pCR) rate
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）
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
