About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
any other chemotherapy, immunotherapy or anticancer agents within 5 years of the first dose of study treatment
injectable hypoglycemics 2. have not have recovered adequately from the toxicity and/or complications from a surgical intervention prior to starting therapy
prior systemic treatment for breast cancer or other malignancies within 5 years of treatment enrollment, except for adequately treated basal cell or squamous skin cancer or in situ cervical cancer. Other malignancies diagnosed more than 5 years before the diagnosis of breast cancer must have been radically treated without evidence of relapse at the moment of patient enrollment in the trial.
has a history of an additional malignancy that is progressing or that has required active treatment in the 5 years prior to breast cancer diagnosis. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer
Trial design
Treatments tested in this trial
- Exercise Therapy
- Fasting-Mimicking Diet
- SOC
Treatment groups
Sponsors and collaborators
Universitaire Ziekenhuizen KU Leuven
Lead sponsor
KU Leuven
Collaborator
AZ Groeninge
Collaborator
Jessa Ziekenhuis Hasselt
Collaborator
UZ Gent, Belgium
Collaborator
UZ Antwerpen
Collaborator
Ziekenhuis ad Stroom, Antwerpen
Collaborator
Institute Gustave Roussy Paris
Collaborator
Universitair Ziekenhuis Brussel
Collaborator