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

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.

Conditions

• Triple Negative Breast Cancer (TNBC), Early Setting

Interventions

OTHER

Exercise 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_SUPPLEMENT

Fasting-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.

DRUG

SOC

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.

Sponsors & Collaborators

• KU Leuven

  collaborator OTHER

• AZ Groeninge

  collaborator UNKNOWN

• Jessa Ziekenhuis Hasselt

  collaborator UNKNOWN

• UZ Gent, Belgium

  collaborator UNKNOWN

• UZ Antwerpen

  collaborator UNKNOWN

• Ziekenhuis ad Stroom, Antwerpen

  collaborator UNKNOWN

• Institute Gustave Roussy Paris

  collaborator UNKNOWN

• Universitair Ziekenhuis Brussel

  collaborator OTHER

• Universitaire Ziekenhuizen KU Leuven

  lead OTHER

Principal Investigators

• Christine Desmedt, PhD · KU Leuven

• Ann Smeets, MD, PhD · UZ Leuven

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-02-01

Primary Completion

2028-09-01

Completion

2031-09-01

Countries

• Belgium

Study Locations