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

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

356

Participants

Timeline

Start Date

May 1, 2025

Primary Completion Date

March 1, 2028

Study Completion Date

March 1, 2031

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.

Trial Locations (10)

Unknown

UZ Antwerpen, Antwerp

Ziekenhuis aan de Stroom, Antwerp

Cliniques universitaires Saint-Luc (UCLouvain), Brussels

UZ Brussel, Brussels

UZ Gent, Ghent

Jessa Ziekenhuis Hasselt, Hasselt

AZ Groeninge, Kortrijk

University Hospital Leuven, Leuven

Centre Hospitalier Universitaire (CHU) UCL Liège, Liège

Centre Hospitalier Universitaire (CHU) UCL Namur, Namur

All Listed Sponsors
collaborator

KU Leuven

OTHER

collaborator

AZ Groeninge

UNKNOWN

collaborator

Jessa Ziekenhuis Hasselt

UNKNOWN

collaborator

UZ Gent, Belgium

UNKNOWN

collaborator

UZ Antwerpen

UNKNOWN

collaborator

Ziekenhuis ad Stroom, Antwerpen

UNKNOWN

collaborator

Institute Gustave Roussy Paris

UNKNOWN

collaborator

Universitair Ziekenhuis Brussel

OTHER

lead

Universitaire Ziekenhuizen KU Leuven

OTHER