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

Recruiting Phase 2 Interventional Study
Triple Negative Breast Cancer (TNBC), Early Setting
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
356 (estimated)
Sponsor
Universitaire Ziekenhuizen KU Leuven · Other
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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.

Trial Locations
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Eligibility Criteria
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…
Contacts

Christine Desmedt, PhD

+3216321194

christine.desmedt@kuleuven.be

CONTACT

Josephine Van Cauwenbenberge, MD

+3216321194

josephine.vancauwenberge@kuleuven.be

CONTACT