Triple-Negative Breast Cancer (TNBC)FAST-01NCT07884721
Fasten Onco Digital Therapy During Neoadjuvant Treatment for Triple-Negative Breast Cancer
A study testing Fasten Onco and Standard Neoadjuvant Treatment in people with Triple-Negative Breast Cancer (TNBC), run by FASTEN at 7 sites in France.
Trial summary
This randomized, multicenter, open-label clinical study will evaluate whether adding the Fasten Onco digital therapy, which supports a fasting-mimicking diet (FMD), to standard neoadjuvant treatment can reduce treatment-related fatigue in adult women with stage II or III triple-negative breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Triple-Negative Breast Cancer (TNBC)
- What is being tested?
- Fasten Onco and Standard Neoadjuvant Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 7 sitesFrance
- Study dates
- 30 Oct 2026to 30 Jun 2029
- Phase
- Interventional
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - Patient has provided written informed consent before participating in the trial.
- Women aged ≥18 years.
- Patient with documented diagnosis of stage II/III triple negative breast cancer (TNBC) as per ESMO guidelines.
- Patient with Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
- Patient has adequate bone marrow function.
- Patient has adequate renal function.
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- Patient has adequate liver function.
- Patient has adequate heart function, i.e., no signs of heart failure or clinically significant arrhythmia.
- Patient has completed the FACIT-Fatigue and FACT-G questionnaires at baseline.
- Patient has access to a smart phone with access to the internet.
- Patient with a weighing scale to measure weight.
- Patient is able and willing to complete the trial, including the assigned questionnaires.
- Patient can read and write in French.
- Patient is covered by the French social security insurance or a similar healthcare insurance.
Who cannot join
- Persons referred to in Articles L1121-5 to L1121-8 of the Public Health Code (covering all protected persons: pregnant women, women in labour, breastfeeding mothers, persons deprived of their liberty by judicial or administrative order, minors, and persons subject to a legal protection measure: guardianship or curatorship).
- Patient with prior breast cancer (invasive or non-invasive breast cancer).
- Patient with a history of cancer within the last 5 years, except for basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix.
- Patient diagnosed with type I or II diabetes and treated.
- Patient with a body mass index (BMI) <18.5 kg/m² or patients with a BMI between 18.5 kg/m² and 20 kg/m² and weight loss ≥5% in the last 3 months or if a BMI >20 kg/m² and weight loss >10% in last 3 months.
- Patient with food allergies.
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- Patient with metabolic disorders affecting gluconeogenesis or adaptation to short periods of fasting.
- Patient already treated with a chronic immunosuppressive drug (dexamethasone used according to SOC is permitted) >10 mg per day of prednisone or equivalent at study entry.
- Previous episodes of symptomatic hypotension leading to loss of consciousness.
- Previous episodes of symptomatic hypoglycemia.
- Patient with behavioral eating disorders.
- Patient already following a fasting or fasting mimicking diet.
- Use of herbal preparations or medications interfering with chemoimmunotherapy pharmacokinetics: St. John's wort, kava, ephedra (ma huang), gingko biloba, aloe vera (and its derivatives), artemisinin (and its derivatives), and dehydroepiandrosterone (DHEA).
- Use of vitamins or food supplements exceeding one-tenth (1/10) of the daily recommended dose except for vitamin D or containing calories.
- Use of any supplement or product with unknown chemical composition.
- Use of pharmacological agents known to interfere with fatigue assessment …
- Use of nutraceutical agents known to interfere with fatigue assessment …
- Agents interfering with FMD and metabolic pathways …
- Patient with medical or psychological condition, in the opinion of the investigator, preventing her from determining the study or giving meaningful informed consent.
- Patient participating in another interventional trial within 30 days prior to randomization.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
France7 sites
Hôpital Privé de Provence
Aix-en-Provence, 13080
Jean-Loup Mouysset, MD
Centre Hospitalier de Bligny
Briis-sous-Forges, 91640
Jean-Baptiste Meric, MD
Hôpital Privé Jean Mermoz
Lyon, 69008
Olfa Derbel, MD
Institut Paoli-Calmettes
Marseille, 13009
Lorène Seguin Seguin, MD
CHU de Montpellier
Montpellier, 34295
Pascal Pujol, MD
Hôpital Américain de Paris
Neuilly-sur-Seine, 92200
Mahasti Saghatchian, MD
Clinique Saint Jean de Dieu
Paris, 75007
About this study
Official title: A Randomized, Multicentric, Open-Label Trial to Investigate the Benefit of Adding Fasten Onco Digital Therapy Integrating a Fasting Mimicking Diet During Neoadjuvant Treatment to Standard of Care, Compared to Standard of Care Alone, in Women (Aged 18 Years or Older), With Early-Stage II/III Triple-Negative Breast Cancer (FAST-01)
This randomized, multicenter, open-label clinical study will evaluate whether adding the Fasten Onco digital therapy, which supports a fasting-mimicking diet (FMD), to standard neoadjuvant treatment can reduce treatment-related fatigue in adult women with stage II or III triple-negative breast cancer.
Participants will be randomly assigned to receive either standard neoadjuvant treatment alone or standard neoadjuvant treatment together with the Fasten Onco program. Participants assigned to Fasten Onco will follow a short fasting-mimicking diet around treatment cycles, supported by the Fasten Onco digital application and under medical supervision.
The main objective is to compare fatigue between the two groups during neoadjuvant treatment. The study will also assess quality of life, treatment-related side effects, pathological response to treatment, and participants' adherence to and satisfaction with the Fasten Onco program.
- Conditions
- Triple-Negative Breast Cancer (TNBC)
- Being tested
- Fasten Onco, Standard Neoadjuvant Treatment
- Keywords
- Neoadjuvant Treatment, Fasting-Mimicking Diet, Digital Therapeutics
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fasten OncoDevice
Fasten Onco is a digital medical device designed to support the implementation of a fasting-mimicking diet (FMD) during neoadjuvant treatment. The device provides a personalized nutritional program synchronized with the participant's treatment schedule, together with educational content, reminders, and guidance to support adherence. The program is prescribed and configured by a healthcare professional and is used under medical supervision.
Standard Neoadjuvant TreatmentDrug
Standard neoadjuvant treatment for stage II/III triple-negative breast cancer according to the standard of care at each participating center. Treatment may include paclitaxel, carboplatin, epirubicin or doxorubicin, cyclophosphamide, and pembrolizumab, used within their approved indications. Standard neoadjuvant treatment is administered in both study groups.
| Study group | Role | What they receive |
|---|---|---|
| FASTEN Group | Experimental | Participants receive standard neoadjuvant treatment plus the Fasten Onco digital therapy integrating a fasting-mimicking diet (FMD). The FMD program is synchronized with neoadjuvant treatment cycles and is supported by the Fasten Onco digital application under medical supervision. Receives: Device: Fasten Onco |
| Standard of Care Group | Active comparator | Participants receive standard neoadjuvant treatment alone, without the Fasten Onco digital therapy or the fasting-mimicking diet (FMD) intervention. Receives: Drug: Standard Neoadjuvant Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in FACIT-Fatigue Total Score
Absolute change from baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) total score. The FACIT-Fatigue is a 13-item questionnaire assessing fatigue and its impact on daily activities and functioning. The total score ranges from 0 to 52, with higher scores indicating less fatigue and better functioning. The primary comparison will assess the difference in change from baseline between the FASTEN Group and the Standard of Care Group.
Measured: Baseline to Day 7 after initiation of Cycle 8 of neoadjuvant treatment
Secondary outcomes (26)
Change From Baseline in FACIT-Fatigue Total Score and Subscores Over the Neoadjuvant Treatment Period
Absolute change from baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) total score and subscores during the neoadjuvant treatment period. The FACIT-Fatigue is a 13-item questionnaire with a total score ranging from 0 to 52, with higher scores indicating less fatigue and better functioning.
Measured: Baseline through Day 7 after initiation of Cycle 8; cycles are generally scheduled every 3 weeks
Time to Definitive Fatigue Worsening
Time from randomization to the first deterioration of ≥6 points out of 52 in the FACIT-Fatigue total score compared with baseline, with no subsequent improvement or deterioration <6 points until the end of the study, or in a participant who drops out after a ≥6-point decrease resulting in missing data or death.
Measured: From randomization through study completion, up to 3 years
FACIT-Fatigue Severity Category
FACIT-Fatigue severity categorized as severe (total score ≤34) or non-severe (total score >34), including shifts from baseline. The Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) is a 13-item questionnaire with a total score ranging from 0 to 52, with higher scores indicating less fatigue and better functioning.
Measured: Baseline through Day 7 after initiation of Cycle 8; cycles are generally scheduled every 3 weeks
Change From Baseline in FACT-G Total Score at Cycle 8
Absolute change from baseline in the Functional Assessment of Cancer Therapy-General (FACT-G) total score. The FACT-G is a 27-item questionnaire assessing physical, social/family, emotional, and functional well-being. The total score ranges from 0 to 108, with higher scores indicating better quality of life.
Measured: Baseline to Day 7 after initiation of Cycle 8; cycles are generally scheduled every 3 weeks
Change From Baseline in FACT-G Total Score Over the Neoadjuvant Treatment Period
Absolute change from baseline in the Functional Assessment of Cancer Therapy-General (FACT-G) total score during the neoadjuvant treatment period. The FACT-G is a 27-item questionnaire assessing physical, social/family, emotional, and functional well-being. The total score ranges from 0 to 108, with higher scores indicating better quality of life.
Measured: Baseline through Day 7 after initiation of Cycle 8; cycles are generally scheduled every 3 weeks
Change From Baseline in FACT-G Domain Scores at Cycle 8
Absolute change from baseline in the four Functional Assessment of Cancer Therapy-General (FACT-G) domain scores: Physical Well-Being (0 to 28), Social/Family Well-Being (0 to 28), Emotional Well-Being (0 to 24), and Functional Well-Being (0 to 28). Higher scores indicate better well-being.
Measured: Baseline to Day 7 after initiation of Cycle 8; cycles are generally scheduled every 3 weeks
Change From Baseline in FACT-G Domain Scores Over the Neoadjuvant Treatment Period
Absolute change from baseline in the four Functional Assessment of Cancer Therapy-General (FACT-G) domain scores during the neoadjuvant treatment period: Physical Well-Being (0 to 28), Social/Family Well-Being (0 to 28), Emotional Well-Being (0 to 24), and Functional Well-Being (0 to 28). Higher scores indicate better well-being.
Measured: Baseline through Day 7 after initiation of Cycle 8; cycles are generally scheduled every 3 weeks
Time to Definitive FACT-G Deterioration
Time from randomization to the first deterioration of ≥5 points out of 108 in FACT-G total score compared with baseline, with no subsequent improvement or deterioration <5 points until the end of the study, or in a participant who drops out after a ≥5-point decrease resulting in missing data or death.
Measured: From randomization through study completion, up to 3 years
Time to Definitive FACT-G Subscore Deterioration
Time from randomization to the first deterioration of ≥3 points in a FACT-G subscore compared with baseline, with no subsequent improvement or deterioration <3 points until the end of the study, or in a participant who drops out after a ≥3-point decrease resulting in missing data or death.
Measured: From randomization through study completion, up to 3 years
Evolution of FACIT-Fatigue and FACT-G Scores and Subscores
Evolution of the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) total score and subscores and the Functional Assessment of Cancer Therapy-General (FACT-G) total score and domain scores during the study, including assessments before and after surgery. The FACIT-Fatigue total score ranges from 0 to 52, with higher scores indicating less fatigue and better functioning. The FACT-G total score ranges from 0 to 108, with higher scores indicating better quality of life.
Measured: Baseline through study completion, up to 3 years
Incidence of Adverse Events
Incidence of adverse events graded according to NCI-CTCAE v5.0, including all AEs, grade ≥3 toxicities, treatment-related AEs, grade ≥3 neutropenia, SAEs, grade ≥3 hematological toxicities, related SAEs, and adverse device effects.
Measured: During treatment through 28 days after the last dose
Pathological Complete Response
Pathological complete response (pCR) assessed at surgery.
Measured: At surgery
Net Treatment Benefit
Net treatment benefit assessed using generalized pairwise comparisons based on prioritized outcomes: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) total score (range 0 to 52, with higher scores indicating less fatigue and better functioning), Functional Assessment of Cancer Therapy-General (FACT-G) total score (range 0 to 108, with higher scores indicating better quality of life), grade ≥3 neutropenia, and pathological complete response.
Measured: From baseline through surgery following completion of neoadjuvant treatment, assessed up to approximately 30 weeks.
Change From Baseline in Body Weight
Absolute change from baseline in body weight, measured in kilograms (kg), during the study, including changes during and between Fasten Onco active fasting-mimicking diet days.
Measured: Baseline through study completion, up to 3 years
Event-Free Survival
Time from randomization to the first occurrence of disease relapse or death from any cause.
Measured: From randomization through study completion, up to 3 years
Overall Survival
Time from randomization to death from any cause.
Measured: From randomization through study completion, up to 3 years
Change From Baseline in FACT-Cog Score and Subscores
Absolute change from baseline in the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog), Version 3, total score and subscale scores. The FACT-Cog assesses four domains: Perceived Cognitive Impairments, Impact of Perceived Cognitive Impairments on Quality of Life, Comments from Others, and Perceived Cognitive Abilities. Using the recommended 33-item scoring algorithm, the total score ranges from 0 to 132, with higher scores indicating better perceived cognitive functioning.
Measured: Baseline to end of neoadjuvant phase and 12 months after end of neoadjuvant phase
Unscheduled Medical Events
Number of days of unscheduled hospitalization, number of unscheduled hospitalizations, and number of emergency consultations.
Measured: From randomization through study completion, up to 3 years
Duration of Neoadjuvant Treatment Exposure
Duration in days from the first administration to the last administration of neoadjuvant treatment.
Measured: From first administration of Cycle 1 through last administration of Cycle 8; cycles are generally scheduled every 3 weeks
Blood Glucose Levels During Fasting-Mimicking Diet Cycles
Blood glucose levels measured by participant self-monitoring at baseline and before and after each fasting-mimicking diet (FMD) cycle.
Measured: Baseline and before and after each 4-day FMD cycle, from Cycle 1 through Cycle 8
Adverse Events Related to the FASTEN Intervention
Incidence of adverse events related to the FASTEN intervention, as assessed by the investigator and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 5.0.
Measured: From initiation of the FASTEN intervention at Cycle 1 through completion of Cycle 8 of neoadjuvant treatment (treatment cycles generally administered every 21 days; approximately 24 weeks).
Patient Satisfaction With Fasten Onco
Patient satisfaction with Fasten Onco assessed using a study-specific 5-point Likert scale ranging from 0 (very dissatisfied) to 4 (very satisfied), with higher scores indicating greater satisfaction.
Measured: After completion of the third Fasten Onco cycle and at completion of Fasten Onco use following Cycle 8 of neoadjuvant treatment (treatment cycles generally administered every 21 days; approximately 24 weeks).
Prognostic Factors for Event-Free Survival
Assessment of the association between prognostic factors and event-free survival (EFS). Prognostic factors evaluated include age, body mass index (BMI), disease stage, node status, tumor-infiltrating lymphocytes at baseline and surgery, Ki-67 grade and proliferation at baseline and surgery, and other identified prognostic factors.
Measured: From randomization through study completion, up to 3 years
Tumor-Infiltrating Lymphocytes
Evolution of tumor-infiltrating lymphocyte levels during the study, when available.
Measured: Baseline and surgery, when available
Change From Baseline in Body Mass Index
Absolute change from baseline in body mass index (BMI), measured in kilograms per square meter (kg/m²), during the study, including changes during and between Fasten Onco active fasting-mimicking diet days.
Measured: Baseline through study completion, up to 3 years
Cumulative Administered Dose of Neoadjuvant Treatment
Total administered dose of neoadjuvant treatment received by each participant during the neoadjuvant treatment period.
Measured: From Cycle 1 through Cycle 8; cycles are generally scheduled every 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2026
- Study start30 Oct 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple-Negative Breast Cancer (TNBC)Studies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FASTEN
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lorène Seguin, MD, Principal investigator, Institut Paoli-Calmettes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07884721
- Sponsor's protocol ID
- FASTEN-01
- Other IDs
- 2025-A02737-42
- Acronym
- FAST-01
- Status last verified
- Oct 2026
- First submitted
- 30 Sep 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified individual participant data are not planned to be made available to researchers outside the study research group.