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.

Trial Details

NCT ID
NCT06831955
Phase
PHASE2
Sponsor
Universitaire Ziekenhuizen KU Leuven
Status
RECRUITING
Cancer Type
Triple Negative (TNBC) Breast Cancer
Interventions
  • Exercise Therapy
  • Fasting-Mimicking Diet
  • SOC
Locations (sample)
  • Antwerp, Belgium|51.22047,4.40026
  • Antwerp, Belgium|51.22047,4.40026
  • Brussels, Belgium|50.85045,4.34878
  • Brussels, Belgium|50.85045,4.34878
  • Ghent, Belgium|51.05,3.71667

Key Eligibility Criteria

  • 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-ex…
  • All histological subtypes are eligible, including but not limited to invasive breast cancer of no special type (NST) , invasive lobular carcinoma (…

For full eligibility, visit ClinicalTrials.gov.

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