drugset / Trial / NCT06831955
LifEStyle Intervention to Enhance Efficacy of Neoadjuvant Therapy in Patients With Triple Negative Breast Cancer
Phase 2
Recruiting
356 enrolled
Universitaire Ziekenhuizen KU Leuven
AZ Groeninge · collabInstitute Gustave Roussy Paris · collabJessa Ziekenhuis Hasselt · collabKU Leuven · collabUZ Antwerpen · collabUZ Gent, Belgium · collabUniversitair Ziekenhuis Brussel · collabZiekenhuis ad Stroom, Antwerpen · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2026-02-01
- Primary completion
- 2028-09-01
- Completion
- 2031-09-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Background | Carboplatin | Small molecule | 1.5 unknown | — |
| Background | Cyclophosphamide | Other / unclassified | 600 mg/m2 | — |
| Background | Epirubicin | Small molecule | 90 mg/m2 | — |
| Background | Paclitaxel | Small molecule | 80 mg/m2 | — |
| Background | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |
| Background | Pembrolizumab | Monoclonal antibody | 400 mg | Intravenous |