Fasting diet and exercise may boost chemo in aggressive breast cancer
NCT ID NCT06831955
First seen Jun 27, 2026 · Last updated Aug 07, 2026 · Updated 1 time
Summary
This study tests whether adding a fasting-mimicking diet and exercise to standard chemotherapy and immunotherapy can improve treatment results for people with early-stage triple negative breast cancer. About 356 participants will be randomly assigned to receive either the lifestyle program plus standard treatment or standard treatment alone. The main goal is to see if the combination leads to a higher rate of complete tumor disappearance before surgery.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 356 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Sep 2031
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * The patient has a biopsy-confirmed diagnosis of stage II-III TNBC 1. Patients with tumor stage T1cN1-2, T2N0-N2, T3N0-N2, T4N0-N2 2. ER and PR negative is defined as an absent or minimal (≤10%) expression of oestrogen and progesterone receptors and absence of HER2 protein over-expression per ASCO/CAP-guidelines 3. All histological subtypes are eligible, including but not limited to invasive breast cancer of no special type (NST) , invasive lobular carcinoma (ILC) etc * WHO/ECOG performance status of grade 0-1 * The participant is able to perform a CPET test (cardiopulmonary exercise testing) * Body mass index ≥ 18.5 kg/m² * Pregnant or breastfeeding women * Presence of adequate bone marrow and organ function * HbA1c \<10% Exclusion Criteria: * had a treatment with any of the following: 1. any other chemotherapy, immunotherapy or anticancer agents within 5 years of the first dose of study treatment 2. injectable hypoglycemics 2. have not have recovered adequately from the toxicity and/or complications from a surgical intervention prior to starting therapy * prior systemic treatment for breast cancer or other malignancies within 5 years of treatment enrollment, except for adequately treated basal cell or squamous skin cancer or in situ cervical cancer. Other malignancies diagnosed more than 5 years before the diagnosis of breast cancer must have been radically treated without evidence of relapse at the moment of patient enrollment in the trial. * has a history of an additional malignancy that is progressing or that has required active treatment in the 5 years prior to breast cancer diagnosis. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer * Prior treatment with anthracyclines * Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137) * Has any disorder, which in the Investigator's opinion might jeopardize the participant's safety or compliance with the protocol * Has, as judged by the investigator, any evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses, or active infection including hepatitis B, hepatitis C, and human immunodeficiency virus (HIV). Screening for chronic conditions is not required * Active autoimmune diseases requiring systemic treatments * Patients with type 1 diabetes mellitus * History of alcohol use disorder (DSM-5) * History of eating disorder (DSM-5)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
10 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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AZ Groeninge
RECRUITINGKortrijk, Belgium
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Centre Hospitalier Universitaire (CHU) UCL Liège
RECRUITINGLiège, Belgium
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Centre Hospitalier Universitaire (CHU) UCL Namur
RECRUITINGNamur, Belgium
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Cliniques universitaires Saint-Luc (UCLouvain)
RECRUITINGBrussels, Belgium
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Jessa Ziekenhuis Hasselt
RECRUITINGHasselt, Belgium
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UZ Antwerpen
RECRUITINGAntwerp, Belgium
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UZ Brussel
RECRUITINGBrussels, Belgium
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UZ Gent
NOT_YET_RECRUITINGGhent, Belgium
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University Hospital Leuven
RECRUITINGLeuven, Belgium
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Ziekenhuis aan de Stroom
NOT_YET_RECRUITINGAntwerp, Belgium
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