Breast CancerPhase 2FACT-TNNCT07378306
FMD and Neoadjuvant Chemo-immunotherapy in TNBC
A Phase 2 study testing Fasting-mimicking diet, Chemotherapy and Toripalimab in people with Breast Cancer, run by Sun Yat-sen University at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Fasting-mimicking diet, Chemotherapy and Toripalimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 5 Mar 2026to 31 Dec 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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).
- Pregnancy must be ruled out for women of childbearing potential (aged 15-49).
Who cannot join
- 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.).
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- 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).
- Active, uncontrolled hepatitis B or hepatitis C.
- Pregnant or lactating women.
- History of diagnosed neurological or psychiatric disorders, including epilepsy or dementia.
- Any other condition deemed by the investigator as unsuitable for participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Jun Tang, MD, +86-20+87343850, tangjun@sysucc.org.cn
Ning Li, PhD, +86-20+87343851, lining@sysucc.org.cn
About this study
Official title: FAsting-mimicking Diet in Combination With Neoadjuvant Chemo-immunoTherapy for Early or Locally Advanced Triple-Negative Breast Cancer: the Prospective, Single-arm, Open-lable, Phase 2 FACT-TN Trial
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).
Read the detailed description
Despite the significantly superior efficacy of neoadjuvant chemoimmunotherapy, a considerable proportion of early-stage treated triple-negative breast cancer (TNBC) patients ultimately experience recurrence, particularly those who do not achieve pathological complete response (pCR) after surgery. Therefore, there is an urgent need to develop new and effective treatment strategies to improve outcomes for TNBC patients. Additionally, selecting patients who are more likely to benefit from neoadjuvant chemotherapy combined with immunotherapy remains a clinical challenge. The fasting-mimicking diet (FMD) is a strictly calorie-restricted, low-sugar, low-protein, and high-fat dietary regimen that shares metabolic and anti-tumor effects with water-only fasting while reducing the risk of severe adverse reactions, leading to extensive exploration in both preclinical and clinical settings. Numerous clinical trials in breast cancer and various other cancers have investigated FMD, consistently demonstrating that FMD enhances the efficacy of standard anti-tumor therapies with a favorable safety profile. Furthermore, FMD has shown potent immunomodulatory effects in both in vivo studies and cancer patients, with the activation of anti-tumor immunity being a key mechanism underlying the anti-cancer effects of FMD alone or in combination with chemotherapy. Based on the above research background, this study focuses on operable early-stage or locally advanced triple-negative or near-triple-negative breast cancer. Patients will receive neoadjuvant standard chemotherapy combined with immunotherapy alongside FMD dietary intervention, aiming to explore the efficacy and safety of FMD dietary intervention in combination with standard neoadjuvant therapy for breast cancer patients.
- Conditions
- Breast Cancer
- Being tested
- Fasting-mimicking diet, Chemotherapy, Toripalimab
- Keywords
- triple-negative breast cancer, fasting-mimicking diet, neoadjuvant, chemo-immunotherapy
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fasting-mimicking dietOther
Also called FMD
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.
ChemotherapyDrug
Also called chemo
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.
ToripalimabDrug
Also called JS001
In the neoadjuvant phase, toripalimab (anti-PD-1) was dosed intravenously at 240 mg on day 1 of every 21-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| FMD plus chemo-immunotherapy | Experimental | The treatment regimen comprises neoadjuvant standard chemotherapy combined with toripalimab, delivered simultaneously with a fasting-mimicking diet intervention. Receives: Other: Fasting-mimicking diet; Drug: Chemotherapy; Drug: Toripalimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One week post-operation for the last enrolled patient
Secondary outcomes (6)
Rate of Residual Cancer Burden (RCB) of 0-1
The number of patients with RCB of 0-1 after neoadjuvant therapy and surgery.
Measured: One week post-operation for the last enrolled patient.
Objective Response Rate (ORR)
The number of patients with complete response and partial response out of the total number of participants
Measured: Two weeks after the end of the final cycle (each cycle is 21 days) for the last enrolled patient.
Event-Free Survival (EFS)
EFS was defined as the time from registration to disease progression (local relapse or distant metastases) or death from any cause, whichever came first
Measured: Three years after the last patient is enrolled
Adverse events (AEs)
Adverse events (AEs) were graded according to NCI CTCAE v5.0.
Measured: One year after the last patient is enrolled
Change in Quality of Life (QoL) scores on the EORTC QLQ-C30 questionnaire
Scores obtained on the scales of the EORTC QLQ-C30. Developed by the EORTC, this self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials.
The questionnaire includes five functional scales (physical, everyday activity, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea and vomiting), a health/quality of life overall scale, and a number of additional elements assessing common symptoms (including dyspnea, loss of appetite, insomnia, constipation, and diarrhea), as well as, the perceived financial impact of the disease. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.
Measured: From baseline to 3 years after surgery
Change in Quality of Life (QoL) scores on the EORTC QLQ-BR 23 questionnaire
This EORTC breast cancer specific QLQ-BR23 questionnaire is intended to supplement the QLQ-C30.
The QLQ-BR23 contains 23 items incorporating five multi-item scales to assess systemic therapy side effects, arm symptoms, breast symptoms, body image and sexual functioning. In addition, single items assess sexual enjoyment, hair loss and future perspective. All items are rated on a four-point Likert-type scale (1 = "not at all", 2 = "a little", 3 = "quite a bit", and 4 = "very much"), and are linearly transformed to a 0-100 scale. For all items but sexual functioning and sexual enjoyment, higher scores indicate more severe symptoms.
Measured: From baseline to 3 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start5 Mar 2026
- Primary completion30 Jun 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Si-Yu Wang, Sun Yat-sen University
- Investigators
- Jun Tang, MD, Principal investigator, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07378306
- Sponsor's protocol ID
- B2025-861-01
- Other IDs
- GASTO-10140
- Acronym
- FACT-TN
- Status last verified
- Apr 2026
- First submitted
- 16 Jan 2026
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Protocol and Statistical Analysis Plan (SAP) will be shared with other researchers after publication of the study.
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FAsting-mimicking Diet in Combination With Neoadjuvant Chemo-immunoTherapy for Early or Locally Advanced Triple-Negative Breast Cancer: the Prospective, Single-arm, Open-lable, Phase 2 FACT-TN Trial
- ClinicalTrials.gov ID
- NCT07378306
- Acronym / sponsor ID
- FACT-TN / B2025-861-01
- Conditions
- Breast Cancer
- Keywords
- triple-negative breast cancer, fasting-mimicking diet, neoadjuvant, chemo-immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 5 Mar 2026 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 30 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Despite the significantly superior efficacy of neoadjuvant chemoimmunotherapy, a considerable proportion of early-stage treated triple-negative breast cancer (TNBC) patients ultimately experience recurrence, particularly those who do not achieve pathological complete response (pCR) after surgery. Therefore, there is an urgent need to develop new and effective treatment strategies to improve outcomes for TNBC patients. Additionally, selecting patients who are more likely to benefit from neoadjuvant chemotherapy combined with immunotherapy remains a clinical challenge. The fasting-mimicking diet (FMD) is a strictly calorie-restricted, low-sugar, low-protein, and high-fat dietary regimen that shares metabolic and anti-tumor effects with water-only fasting while reducing the risk of severe adverse reactions, leading to extensive exploration in both preclinical and clinical settings. Numerous clinical trials in breast cancer and various other cancers have investigated FMD, consistently demonstrating that FMD enhances the efficacy of standard anti-tumor therapies with a favorable safety profile. Furthermore, FMD has shown potent immunomodulatory effects in both in vivo studies and cancer patients, with the activation of anti-tumor immunity being a key mechanism underlying the anti-cancer effects of FMD alone or in combination with chemotherapy. Based on the above research background, this study focuses on operable early-stage or locally advanced triple-negative or near-triple-negative breast cancer. Patients will receive neoadjuvant standard chemotherapy combined with immunotherapy alongside FMD dietary intervention, aiming to explore the efficacy and safety of FMD dietary intervention in combination with standard neoadjuvant therapy for breast cancer patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FMD plus chemo-immunotherapy | Experimental | Other: Fasting-mimicking diet, Drug: Chemotherapy, Drug: ToripalimabThe treatment regimen comprises neoadjuvant standard chemotherapy combined with toripalimab, delivered simultaneously with a fasting-mimicking diet intervention. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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.
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fasting-mimicking dietAlso: FMDThe 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. | Other | FMD plus chemo-immunotherapy |
| ChemotherapyAlso: chemoAll 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. | Drug | FMD plus chemo-immunotherapy |
| ToripalimabAlso: JS001In the neoadjuvant phase, toripalimab (anti-PD-1) was dosed intravenously at 240 mg on day 1 of every 21-day cycle. | Drug | FMD plus chemo-immunotherapy |
Primary outcome
Total pathological complete response (pCR) rate
Time frame: One week post-operation for the last enrolled patient
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.
6 secondary outcomes
Rate of Residual Cancer Burden (RCB) of 0-1
Time frame: One week post-operation for the last enrolled patient.
Objective Response Rate (ORR)
Time frame: Two weeks after the end of the final cycle (each cycle is 21 days) for the last enrolled patient.
Event-Free Survival (EFS)
Time frame: Three years after the last patient is enrolled
Adverse events (AEs)
Time frame: One year after the last patient is enrolled
Change in Quality of Life (QoL) scores on the EORTC QLQ-C30 questionnaire
Time frame: From baseline to 3 years after surgery
Change in Quality of Life (QoL) scores on the EORTC QLQ-BR 23 questionnaire
Time frame: From baseline to 3 years after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Individual participant dataSharing planned: Yes. Study Protocol and Statistical Analysis Plan (SAP) will be shared with other researchers after publication of the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jun Tang, MD principal investigator
Sun Yat-Sen University Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fasting-mimicking diet, Chemotherapy and Toripalimab in people with Breast Cancer, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jun Tang, MD (+86-20-87343850, tangjun@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total pathological complete response (pCR) rate (time frame: One week post-operation for the last enrolled patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.