Actively Recruiting

Phase 2
Age: 18Years - 70Years
FEMALE
NCT07378306

FMD and Neoadjuvant Chemo-immunotherapy in TNBC

Led by Sun Yat-sen University · Updated on 2026-04-21

80

Participants Needed

1

Research Sites

199 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

FMD and Neoadjuvant Chemo-immunotherapy in TNBC

Who Can Participate

Age: 18Years - 70Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Provided written informed consent.
  • Willing and able to follow the prescribed dietary intervention, treatment schedule, tests, and visits.
  • Female, aged 18 to 70 years.
  • ECOG performance status of 0 to 1 with expected survival over 12 weeks.
  • Female patients of childbearing potential agree to reliable contraception before, during, and 8 weeks after the study.
  • Pathologically confirmed primary breast cancer with tumor size ≥2 cm and lymph node status N0-N3; any tumor size if lymph nodes positive; no distant metastases.
  • Triple-negative or near-triple-negative subtype (HR-negative or low ER/PR expression 1%-10%, HER2-negative).
  • No prior anti-tumor therapy including chemotherapy, radiotherapy, or biological therapy.
  • Hemoglobin ≥90 g/L (can be maintained by transfusion).
  • Absolute neutrophil count ≥1.5 × 10^9/L.
  • Platelet count ≥100 × 10^9/L.
  • Total bilirubin ≤1.5 times upper limit of normal (ULN).
  • ALT and AST ≤2.5 times ULN.
  • Creatinine ≤1.5 times ULN.
  • Fasting blood glucose <250 mg/dL.
  • Pregnancy ruled out for women of childbearing potential (aged 15-49).
Not Eligible

You will not qualify if you...

  • Previous systemic anti-cancer therapy including chemotherapy, targeted therapy, immunotherapy, or investigational treatment.
  • Prior radiotherapy for breast cancer.
  • Evidence of distant metastasis before treatment.
  • Another malignancy within 5 years except certain cured cancers.
  • Allergy or hypersensitivity to investigational drugs or products.
  • Active autoimmune disease requiring systemic treatment.
  • Body Mass Index (BMI) below 19 kg/m².
  • Unintentional weight loss >5% in past 3 months unless BMI >22 kg/m² and weight loss <10%, or >10% unless BMI >25 kg/m² and weight loss <15%; weight stable for at least 1 month before enrollment.
  • Eating disorders such as anorexia or bulimia nervosa.
  • Baseline fasting blood glucose ≤60 mg/dL.
  • Severe infection within 4 weeks prior to enrollment.
  • Diabetes mellitus type 1 or 2 requiring medication except metformin.
  • Unstable systemic disease including uncontrolled hypertension, recent angina, heart failure, or recent myocardial infarction.
  • Severe arrhythmia requiring medication or significant liver, kidney, or metabolic disease.
  • Infection with HIV.
  • Active uncontrolled hepatitis B or C.
  • Pregnant or breastfeeding women.
  • Diagnosed neurological or psychiatric disorders including epilepsy or dementia.
  • Any other condition considered unsuitable by the investigator.

AI-Screening

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Trial Site Locations

Total: 1 location

1

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China, 510060

Actively Recruiting

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Research Team

J

Jun Tang, MD

CONTACT

N

Ning Li, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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