RecruitingPhase 2

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

Belgium356 participantsStarted 2026-02-01

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

Pathological Complete Response (pCR)

Timeframe: Surgical specimen (at the time of surgery)

Trial details

NCT IDNCT06831955

SponsorUniversitaire Ziekenhuizen KU Leuven

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-09-01

Contact for this trial

Christine Desmedt, PhD

+3216321194 christine.desmedt@kuleuven.be

View on ClinicalTrials.gov More Triple Negative Breast Cancer (TNBC), Early Setting trials