RecruitingPhase 2NCT06831955

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

The LESLIE Trial: LifEStyle Intervention to Enhance Efficacy of Neoadjuvant Systemic Therapy in Patients With Triple Negative Breast Cancer


Sponsor

Universitaire Ziekenhuizen KU Leuven

Enrollment

356 participants

Start Date

Feb 1, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying Exercise Therapy, Fasting-Mimicking Diet, and others for people with triple negative breast cancer (tnbc), early setting. The study is currently recruiting participants at 10 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERExercise Therapy

The exercise regimen consists of a non-linear aerobic exercise program of 3-4 sessions per week. During days of FMD no exercise will be prescribed.

DIETARY_SUPPLEMENTFasting-Mimicking Diet

The FMD is a plant-based, low-carbohydrate, low-caloric diet of 4 days , with the fourth day being the day of chemo/immunotherapy. A total of 6 FMD cycles will be administered over the treatment period of 20 weeks.

DRUGSOC

Four cycles of an intravenous infusion of pembrolizumab (200 mg) once every 3 weeks plus paclitaxel (80 mg per square meter of body-surface area once weekly) plus carboplatin (at a dose based on an area under the concentration-time curve of 1.5 mg per milliliter per minute) once weekly in the first 12 weeks, followed by four cycles of epirubicin (90 mg per square meter) plus cyclophosphamide (600 mg per square meter) once every 2 weeks plus pembrolizumab 400mg every 6 weeks or pembrolizumab 200mg every 3 weeks in the subsequent 8 weeks.


Locations(10)

UZ Antwerpen

Antwerp, Belgium

Ziekenhuis aan de Stroom

Antwerp, Belgium

Cliniques universitaires Saint-Luc (UCLouvain)

Brussels, Belgium

UZ Brussel

Brussels, Belgium

UZ Gent

Ghent, Belgium

Jessa Ziekenhuis Hasselt

Hasselt, Belgium

AZ Groeninge

Kortrijk, Belgium

University Hospital Leuven

Leuven, Belgium

Centre Hospitalier Universitaire (CHU) UCL Liège

Liège, Belgium

Centre Hospitalier Universitaire (CHU) UCL Namur

Namur, Belgium

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NCT06831955