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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversitaire Ziekenhuizen KU Leuven

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

356 Participants
are divided into 2 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