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

Study acronym: LESLIE
StatusRecruiting
PhasePhase 2
Started2026-02-01
View on ClinicalTrials.gov ↗

Amendment history

2026-08-04
Study Status, Sponsor/Collaborators v2
Collaborators8 to 10 entries
InstituteCentre GustaveHospitalier RoussyUniversitaire ParisUCLouvain Namur Centre Hospitalier Universitaire de Liege Cliniques universitaires Saint-Luc- Université Catholique de Louvain
2026-03-18
Not Yet Recruiting→Recruiting Study Status, Oversight, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2028-03-01→2028-09-01
Completion date2031-03-01→2031-09-01
Start dateestimated 2025-05-01→confirmed 2026-02-01
Study sitesdetails revised at 10 of 10 sites
2025-02-12
Original filing
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.
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