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Fasting diet and exercise may boost chemo in aggressive breast cancer

NCT ID NCT06831955

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 356 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2026

Expected to finish

Sep 2031

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    10 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • AZ Groeninge

    RECRUITING

    Kortrijk, Belgium

  • Centre Hospitalier Universitaire (CHU) UCL Liège

    RECRUITING

    Liège, Belgium

  • Centre Hospitalier Universitaire (CHU) UCL Namur

    RECRUITING

    Namur, Belgium

  • Cliniques universitaires Saint-Luc (UCLouvain)

    RECRUITING

    Brussels, Belgium

  • Jessa Ziekenhuis Hasselt

    RECRUITING

    Hasselt, Belgium

  • UZ Antwerpen

    RECRUITING

    Antwerp, Belgium

  • UZ Brussel

    RECRUITING

    Brussels, Belgium

  • UZ Gent

    NOT_YET_RECRUITING

    Ghent, Belgium

  • University Hospital Leuven

    RECRUITING

    Leuven, Belgium

  • Ziekenhuis aan de Stroom

    NOT_YET_RECRUITING

    Antwerp, Belgium

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