Lifestyle program to boost pre-surgery treatment for early triple-negative breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

LESLIE is a randomized Phase IIb trial enrolling 356 people with stage II–III triple-negative breast cancer and randomizing them 2:1 to standard neoadjuvant chemo-immunotherapy with or without a cyclic fasting-mimicking diet combined with structured exercise. Neoadjuvant therapy follows a Keynote-522–style regimen over about 21 weeks, and participants in the interventional arm receive regular physiotherapy visits and online dietitian support while undergoing cyclic FMD during treatment cycles. The trial measures treatment response and tolerability as key outcomes, with secondary endpoints including therapy compliance, quality of life, and longer-term survival. The study is multicenter within Belgium and integrates lifestyle support alongside standard oncology care.

Why it matters

Who can join: the full rules

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)

Where it's running

• UZ Antwerpen
  Antwerp, Belgium Recruiting
• Cliniques universitaires Saint-Luc (UCLouvain)
  Brussels, Belgium Recruiting
• UZ Brussel
  Brussels, Belgium Recruiting
• Jessa Ziekenhuis Hasselt
  Hasselt, Belgium Recruiting
• AZ Groeninge
  Kortrijk, Belgium Recruiting
• University Hospital Leuven
  Leuven, Belgium Recruiting

Study contacts

• Principal investigator: Christine Desmedt, PhD — KU Leuven
• Study coordinator: Christine Desmedt, PhD
• Email: christine.desmedt@kuleuven.be
• Phone: +3216321194

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.