Fasting-Mimicking Diet as an Adjunct to Neoadjuvant Chemotherapy for Hormone-Receptor-Positive Br⦠(NCT07077018) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Fasting-Mimicking Diet as an Adjunct to Neoadjuvant Chemotherapy for Hormone-Receptor-Positive Breast Cancer
China45 participantsStarted 2025-07-12
Plain-language 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%).
Who can participate
Age range18 Years ā 75 Years
SexALL
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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 ā„40%. 3)T3-T4
* Age 18-75 years at enrollment
* Body mass index (BMI) ā„18.5 kg/m²
* Adequate hematological function:1ļ¼White blood cell count\>3.0Ć10ā¹/L.2)Absolute neutrophil count ā„1.5Ć10ā¹/L.3)Platelets ā„100Ć10ā¹/L.
* Adequate organ function:1ļ¼Total bilirubin ā¤1.5 Ć upper limit of normal (ULN).2ļ¼ALT/AST ā¤2.5 Ć ULN. 3ļ¼Alkaline phosphatase ā¤5 Ć ULN.4ļ¼Creatinine clearance ā„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.