LifEStyle Intervention to Enhance Efficacy of Neoadjuvant 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.

Inclusion Criteria: * The patient has a biopsy-confirmed diagnosis of stage II-III TNBC 1. Patients with tumor stage T1cN1-2, T2N0-N2, T3N0-N2, T4N0-N2 2. 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 3. 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 \