FMD and Neoadjuvant Chemo-immunotherapy in TNBC (NCT07378306) | Clinical Trial Compass
RecruitingPhase 2
FMD and Neoadjuvant Chemo-immunotherapy in TNBC
China80 participantsStarted 2026-03-05
Plain-language summary
The primary objective of this study is to investigate the efficacy and safety of a fasting-mimicking diet (FMD) intervention combined with standard neoadjuvant chemoimmunotherapy in early-stage or locally advanced triple-negative breast cancer (TNBC).
Who can participate
Age range18 Years – 70 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Written informed consent obtained from the patient or their legal representative.
* Good patient compliance, willing and able to adhere to the prescribed dietary intervention plan, visits, treatment schedule, laboratory tests, and other study procedures.
* Female, aged 18 to 70 years.
* ECOG performance status score of 0 to 1, with an expected survival of \>12 weeks.
* Female patients of childbearing potential must agree to use reliable methods of contraception from before trial entry, throughout the study, and for 8 weeks after the completion of the study.
* Patients with pathologically confirmed primary breast cancer, with a primary tumor ≥2 cm and regional lymph node status N0-N3 (AJCC Version 8); patients with positive lymph nodes may have a primary tumor of any size; no distant metastases (M0).
* Triple-negative or near-triple-negative subtype, defined as HR-negative or low expression (ER and/or PR positivity rate 1%-10%) and HER2-negative (IHC 0, 1+, or 2+ with FISH-negative).
* No prior history of any anti-tumor therapy, including chemotherapy, radiotherapy, and biological therapy.
* Hemoglobin ≥90 g/L (can be maintained or exceed this level via transfusion).
* Absolute neutrophil count ≥1.5 × 10E9/L.
* Platelet count ≥100 × 10E9/L.
* Total bilirubin ≤1.5 × upper limit of normal (ULN).
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN.
* Creatinine ≤1.5 × ULN.
* Fasting blood glucose \<250 mg/dL (13.89 mmol/L).
* Pr…
What they're measuring
1
Total pathological complete response (pCR) rate
Timeframe: One week post-operation for the last enrolled patient