NCT06831955 LifEStyle Intervention to Enhance Efficacy of Neoadjuvant Therapy in Patients With Triple Negative Breast Cancer

Eligibility & Interventions

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.

This trial targets 356 participants in total. It began in 2026-02-01 with a primary completion date of 2028-09-01.

Brief Summary

LESLIE is a multicentric randomized controlled trial in patients with triple negative breast cancer receiving neoadjuvant chemo/immunotherapy (NAT). This trial investigates the hypothesis that adding a cyclic fasting-mimicking diet combined with exercise during the NAT improves the NAT's therapeutic efficacy, treatment tolerability and compliance, as well as improve quality of life.

Eligibility Criteria

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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