Actively Recruiting
LifEStyle Intervention to Enhance Efficacy of Neoadjuvant Therapy in Patients With Triple Negative Breast Cancer
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2026-03-20
356
Participants Needed
10
Research Sites
291 weeks
Total Duration
On this page
Sponsors
U
Universitaire Ziekenhuizen KU Leuven
Lead Sponsor
K
KU Leuven
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
LifEStyle Intervention to Enhance Efficacy of Neoadjuvant Therapy in Patients With Triple Negative Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Biopsy-confirmed diagnosis of stage II-III triple negative breast cancer (tumor stages T1cN1-2, T2N0-N2, T3N0-N2, T4N0-N2)
- Estrogen receptor and progesterone receptor negative (≤10% expression) with absence of HER2 over-expression
- All histological subtypes of breast cancer including invasive breast cancer of no special type and invasive lobular carcinoma
- WHO/ECOG performance status grade 0-1
- Ability to perform cardiopulmonary exercise testing (CPET)
- Body mass index of 18.5 kg/m² or higher
- Presence of adequate bone marrow and organ function
- HbA1c less than 10%
You will not qualify if you...
- Previous chemotherapy, immunotherapy, or anticancer treatment within 5 years before starting study treatment
- Injectable hypoglycemic treatment or unresolved toxicity/complications from surgery before therapy
- Prior systemic treatment for breast or other cancers within 5 years, except treated basal cell or squamous skin cancer or in situ cervical cancer
- History of additional malignancy requiring treatment or progressing within 5 years before breast cancer diagnosis, except treated skin or cervical cancers
- Prior treatment with anthracyclines
- Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, or other co-inhibitory T-cell receptor agents
- Any disorder that may jeopardize safety or compliance as judged by the investigator
- Severe or uncontrolled systemic diseases, active bleeding, or active infections including hepatitis B, hepatitis C, or HIV
- Active autoimmune diseases requiring systemic treatment
- Type 1 diabetes mellitus
- History of alcohol use disorder
- History of eating disorder
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
UZ Antwerpen
Antwerp, Belgium
Actively Recruiting
2
Ziekenhuis aan de Stroom
Antwerp, Belgium
Not Yet Recruiting
3
Cliniques universitaires Saint-Luc (UCLouvain)
Brussels, Belgium
Actively Recruiting
4
UZ Brussel
Brussels, Belgium
Actively Recruiting
5
UZ Gent
Ghent, Belgium
Not Yet Recruiting
6
Jessa Ziekenhuis Hasselt
Hasselt, Belgium
Actively Recruiting
7
AZ Groeninge
Kortrijk, Belgium
Actively Recruiting
8
University Hospital Leuven
Leuven, Belgium
Actively Recruiting
9
Centre Hospitalier Universitaire (CHU) UCL Liège
Liège, Belgium
Actively Recruiting
10
Centre Hospitalier Universitaire (CHU) UCL Namur
Namur, Belgium
Actively Recruiting
Research Team
C
Christine Desmedt, PhD
CONTACT
J
Josephine Van Cauwenbenberge, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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