Fasting-Mimicking Diet as an Adjunct to Neoadjuvant Chemotherapy for Hormone-Receptor-Positive Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Pathological complete response (pCR) rate
研究概览
简要总结
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%).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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
排除标准
- •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.
研究组 & 干预措施
FMD Group
干预措施: Fasting-mimicking diet (FMD) Group (Dietary Supplement)
结局指标
主要结局
Pathological complete response (pCR) rate
时间窗: 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）
次要结局
未报告次要终点
研究者
Kun Wang
Professor
Guangdong Provincial People's Hospital