Clinical Trial

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

Study acronym: LESLIE
Recruiting Phase 2
View on ClinicalTrials.gov →
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-02-12.
Status change: Not Yet Recruiting → Recruiting 2026-03-18
Trial Details
NCT Number NCT06831955
Lead Sponsor Universitaire Ziekenhuizen KU Leuven
Collaborators: KU Leuven, AZ Groeninge, Jessa Ziekenhuis Hasselt, UZ Gent, Belgium, UZ Antwerpen, Ziekenhuis ad Stroom, Antwerpen, Universitair Ziekenhuis Brussel, Centre Hospitalier Universitaire UCLouvain Namur, Centre Hospitalier Universitaire de Liege, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Conditions Triple Negative Breast Cancer (TNBC), Early Setting
Enrollment 356 participants
Start Date 2026-02-01
Primary Completion 2028-09-01 (estimated)
Study Completion 2031-09-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-07