FMD and Neoadjuvant Chemo-immunotherapy in TNBC

NCT07378306 | Recruiting Phase 2 DMC

• 2 other identifiers: B2025-861-01GASTO-10140
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Breast Cancer

Keywords

triple-negative breast cancer; fasting-mimicking diet; neoadjuvant; chemo-immunotherapy

Outcome Measures

Primary Outcomes (1)

• Total pathological complete response (pCR) rate

  The number of patients with pCR out of the total number of participants using a definition of ypT0/Tis ypN0 after neoadjuvant therapy and surgery.

  One week post-operation for the last enrolled patient

Secondary Outcomes (6)

• Rate of Residual Cancer Burden (RCB) of 0-1

  One week post-operation for the last enrolled patient.

• Objective Response Rate (ORR)

  Two weeks after the end of the final cycle (each cycle is 21 days) for the last enrolled patient.

• Event-Free Survival (EFS)

  Three years after the last patient is enrolled

• Adverse events (AEs)

  One year after the last patient is enrolled

• Change in Quality of Life (QoL) scores on the EORTC QLQ-C30 questionnaire

  From baseline to 3 years after surgery

Study Arms (1)

FMD plus chemo-immunotherapy

EXPERIMENTAL

The treatment regimen comprises neoadjuvant standard chemotherapy combined with toripalimab, delivered simultaneously with a fasting-mimicking diet intervention.

Other: Fasting-mimicking diet; Drug: Chemotherapy; Drug: Toripalimab

Interventions

Fasting-mimicking diet OTHER

The Fasting-Mimicking Diet (FMD) will be administered every three weeks for a maximum of 8 consecutive cycles, unless side effects necessitate its temporary or permanent discontinuation. Each FMD cycle will consist of a specific FMD regimen for five consecutive days, repeated every three weeks. The FMD regimen is a plant-based, low-calorie (approximately 738 kcal on Day 1; approximately 536 kcal on Days 2 to 5), low-protein, low-carbohydrate diet. All patients will follow the identical prescribed FMD regimen. No modifications or personalization to the prescribed FMD plan is permitted. The first FMD cycle will commence two days before the administration of the first cycle of chemoimmunotherapy, be applied on the day of chemotherapy, and continue for two additional days after chemotherapy concludes.

Also known as: FMD

FMD plus chemo-immunotherapy

Chemotherapy DRUG

All enrolled patients received standard preoperative chemotherapy combined with anti-PD-1 therapy. The neoadjuvant regimens were guideline-recommended protocols: TP×4-AC×4 combined with PD-1 inhibitor, TP plus PD-1 inhibitor, or PD-1 inhibitor combined with other taxane-based regimens. * T: Taxanes, including docetaxel, nab-paclitaxel, and paclitaxel. * P: Platinum agents. * A: Anthracyclines, including epirubicin, pirarubicin, and doxorubicin. * C: Cyclophosphamide.

Also known as: chemo

FMD plus chemo-immunotherapy

Toripalimab DRUG

In the neoadjuvant phase, toripalimab (anti-PD-1) was dosed intravenously at 240 mg on day 1 of every 21-day cycle.

Also known as: JS001

FMD plus chemo-immunotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Previous administration of any systemic anti-cancer therapy, including cytotoxic chemotherapy, targeted therapy, immunotherapy, or investigational treatment.
• Prior radiotherapy for breast cancer.
• Documented evidence (pathological or radiological) of distant metastasis prior to treatment initiation.
• History of another malignancy within the five years preceding treatment initiation in this study, except for carcinoma in situ of the cervix, cured basal cell carcinoma, or urothelial tumors of the bladder (including Ta and Tis).
• Known allergy or hypersensitivity to any component of the investigational drugs or products.
• Active autoimmune disease requiring systemic treatment (e.g., systemic lupus erythematosus, psoriasis, etc.).
• Body Mass Index (BMI) \< 19 kg/m².
• Unintentional weight loss ≥5% within the past 3 months, unless the patient's BMI \>22 kg/m² and weight loss at study entry is \<10%; or unintentional weight loss ≥10% within the past 3 months, unless the patient's BMI \>25 kg/m² and weight loss at study entry is \<15%. In either case, weight must have been stable for at least one month prior to enrollment.
• Eating disorders, including anorexia nervosa, bulimia nervosa, etc.
• Baseline fasting blood glucose ≤60 mg/dL (3.33 mmol/L).
• Severe infection within 4 weeks prior to enrollment, including but not limited to hospitalization for infectious complications, bacteremia, or severe pneumonia.
• Type 1 or Type 2 diabetes mellitus requiring medication (including but not limited to insulin or insulin secretagogues), with the exception of metformin.
• Any unstable systemic disease, including: uncontrolled hypertension, unstable angina, angina pectoris with onset within the last 3 months, congestive heart failure, myocardial infarction (within 6 months prior to enrollment).
• Severe arrhythmia requiring medication, or significant hepatic, renal, or metabolic disease.
• Known infection with Human Immunodeficiency Virus (HIV).

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Triple Negative Breast Neoplasms

Interventions

Drug Therapy; toripalimab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Jun Tang, MD

  Sun Yat-Sen University Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Tang, MD

CONTACT

+86-20-87343850; tangjun@sysucc.org.cn

Ning Li, PhD

CONTACT

+86-20-87343851; lining@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 16, 2026
• First Posted: January 30, 2026
• Study Start: March 5, 2026
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

CN (1)