An interventional study of Fasten Onco and Standard Neoadjuvant Treatment in Triple-Negative Breast Cancer (TNBC), sponsored by FASTEN. Not yet recruiting at 7 sites in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by FASTEN · Not applicable, Interventional, and Supportive care
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.
1,163 studies on the registry are indexed under Triple Negative Breast Neoplasms; 447 are open to participants now.
This study's planned enrollment of 144 is above the median of 61 across 1,001 interventional studies indexed under Triple Negative Breast Neoplasms.
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Exclusion Criteria:
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.
Device: Fasten Onco
Participants receive standard neoadjuvant treatment alone, without the Fasten Onco digital therapy or the fasting-mimicking diet (FMD) intervention.
Drug: Standard Neoadjuvant Treatment
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 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.
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.
Time frame: Baseline to Day 7 after initiation of Cycle 8 of neoadjuvant treatment
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: During treatment through 28 days after the last dose
Pathological Complete Response
Pathological complete response (pCR) assessed at surgery.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From randomization through study completion, up to 3 years
Overall Survival
Time from randomization to death from any cause.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From randomization through study completion, up to 3 years
Tumor-Infiltrating Lymphocytes
Evolution of tumor-infiltrating lymphocyte levels during the study, when available.
Time frame: 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.
Time frame: 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.
Time frame: From Cycle 1 through Cycle 8; cycles are generally scheduled every 3 weeks
Dose Intensity of Neoadjuvant Treatment
Dose intensity calculated as the total administered dose as a proportion of the total planned dose.
Time frame: From Cycle 1 through Cycle 8; cycles are generally scheduled every 3 weeks
Number of Neoadjuvant Treatment Cycles Received
Number of neoadjuvant treatment cycles received by each participant.
Time frame: From Cycle 1 through Cycle 8; cycles are generally scheduled every 3 weeks
Number of Neoadjuvant Treatment Dose Delays
Number of dose delays occurring during neoadjuvant treatment.
Time frame: From Cycle 1 through Cycle 8; cycles are generally scheduled every 3 weeks
Neoadjuvant Treatment Discontinuation
Number of participants who permanently discontinue neoadjuvant treatment before planned completion. Reasons for discontinuation will be recorded.
Time frame: From Cycle 1 through Cycle 8; cycles are generally scheduled every 3 weeks
Blood Ketone Levels During Fasting-Mimicking Diet Cycles
Blood ketone levels measured by participant self-monitoring at baseline and before and after each fasting-mimicking diet (FMD) cycle.
Time frame: Baseline and before and after each 4-day FMD cycle, from Cycle 1 through Cycle 8
Proportion of Fasting-Mimicking Diet Cycles Completed
Proportion of fasting-mimicking diet (FMD) cycles completed relative to the number of neoadjuvant treatment cycles received by each participant.
Time frame: From Cycle 1 through Cycle 8; each FMD cycle lasts 4 days
Duration of Fasten Onco Application Use
Duration of use of the Fasten Onco application by each participant, measured in days.
Time frame: From initiation of Fasten Onco at Cycle 1 through completion of Cycle 8 of neoadjuvant treatment (treatment cycles generally administered every 21 days; approximately 24 weeks).
Time Spent Using the Fasten Onco Application
Total time spent using the Fasten Onco application by each participant during the neoadjuvant treatment period, measured in minutes.
Time frame: From Cycle 1 through completion of Cycle 8 of neoadjuvant treatment (treatment cycles generally administered every 21 days; approximately 24 weeks).
Accuracy of Fasten Onco Synchronization With Neoadjuvant Treatment
Proportion of Fasten Onco fasting-mimicking diet cycles correctly synchronized with the corresponding neoadjuvant treatment cycles.
Time frame: From Cycle 1 through Cycle 8 of neoadjuvant treatment (treatment cycles generally administered every 21 days; approximately 24 weeks).
Investigator Satisfaction With Fasten Onco
Investigator satisfaction with Fasten Onco assessed using a 5-point Likert scale ranging from 0 (very dissatisfied) to 4 (very satisfied), with higher scores indicating greater satisfaction.
Time frame: At completion of Cycle 8 for the last participant at each study center (treatment cycles generally administered every 21 days; approximately 24 weeks after Cycle 1 for that participant).
Time Required for Patient Registration in Fasten Onco
Time spent by the oncologist to register a participant in Fasten Onco.
Time frame: At baseline, during initial participant registration in Fasten Onco, before initiation of Cycle 1.
Usability of Fasten Onco Assessed With the French System Usability Scale
Usability of Fasten Onco assessed using the French version of the System Usability Scale (F-SUS). The F-SUS consists of 10 items and provides a total score ranging from 0 to 100, with higher scores indicating better perceived usability.
Time frame: After completion of the third Fasten Onco cycle (approximately 9 weeks after initiation, if aligned with the 21-day neoadjuvant treatment cycles)
Prognostic Factors for Overall Survival
Assessment of the association between prognostic factors and overall survival (OS). 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.
Time frame: From randomization through study completion, up to 3 years
Plan to share: No — De-identified individual participant data are not planned to be made available to researchers outside the study research group.
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