The LESLIE Trial: LifEStyle Intervention to Enhance Efficacy of Neoadjuvant Systemic Therapy in Patients With Triple Negative Breast Cancer
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.
• The patient has a biopsy-confirmed diagnosis of stage II-III TNBC
‣ Patients with tumor stage T1cN1-2, T2N0-N2, T3N0-N2, T4N0-N2
⁃ ER and PR negative is defined as an absent or minimal (≤10%) expression of oestrogen and progesterone receptors and absence of HER2 protein over-expression per ASCO/CAP-guidelines
⁃ All histological subtypes are eligible, including but not limited to invasive breast cancer of no special type (NST) , invasive lobular carcinoma (ILC) etc
• WHO/ECOG performance status of grade 0-1
• The participant is able to perform a CPET test (cardiopulmonary exercise testing)
• Body mass index ≥ 18.5 kg/m²
• Pregnant or breastfeeding women
• Presence of adequate bone marrow and organ function
• HbA1c \<10%