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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Exercise Therapy
Other interventionThe exercise regimen consists of a non-linear aerobic exercise program of 3-4 sessions per week. During days of FMD no exercise will be prescribed.
Fasting-Mimicking Diet
Dietary supplementThe FMD is a plant-based, low-carbohydrate, low-caloric diet of 4 days , with the fourth day being the day of chemo/immunotherapy. A total of 6 FMD cycles will be administered over the treatment period of 20 weeks.
SOC
DrugFour cycles of an intravenous infusion of pembrolizumab (200 mg) once every 3 weeks plus paclitaxel (80 mg per square meter of body-surface area once weekly) plus carboplatin (at a dose based on an area under the concentration-time curve of 1.5 mg per milliliter per minute) once weekly in the first 12 weeks, followed by four cycles of epirubicin (90 mg per square meter) plus cyclophosphamide (600 mg per square meter) once every 2 weeks plus pembrolizumab 400mg every 6 weeks or pembrolizumab 200mg every 3 weeks in the subsequent 8 weeks.
Treatment groups
356 Participants
are divided into 2 treatment groupsGroup A: Arm A: control armActive comparator 1 intervention
Group B: Arm B: Intervention armExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Pathological Complete Response (pCR)
pCR, ypT0/Tis ypN0: no invasive residual disease in breast or regional lymph nodes; residual in situ disease allowed
Time frame
Surgical specimen (at the time of surgery)Secondary outcomes
1
Adherence and compliance to FMD
Adherence is defined as the ratio of how many days the patient complies to the FMD (without 2 minor or 1 major deviation), divided by the in total 24 planned days of FMD. Compliance will be measured at the end of each FMD cycle based on the incidence of minor and major deviations from the prescribed dietary regimen.
Time frame
20 weeks, in case of dose delays up to 30 weeks2
Adherence and compliance to exercise therapy
Exercise attendance is calculated as the number of training sessions attended divided by the total 75 planned sessions. Compliance is calculated based on the relative dose intensity (RDI). Relative dose intensity (RDI) is defined as the ratio of total completed to total planned cumulative dose, expressed as a percentage.
Time frame
20 weeks, in case of dose delays up to 30 weeks3
Adverse Event profile
The type, incidence, severity (as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\] v5.0), seriousness, time till onset and duration of Adverse Events (AEs)/SAEs, immune-related AEs and any laboratory abnormalities
Time frame
Following completion of the NAT, subjects will be followed for 30 days for AEs, SAEs will be collected for 90 days after completion of NAT. An exception is made for heart failure which will be collected till 1 year after NAT.4
Systemic Treatment Completion
RDI is defined as the amount of drug administered per unit of time (=delivered total dose in mg/m2 divided by actual time used to complete treatment in a number of weeks) as a fraction of the standard amount of drug per unit of time (=standard total dose in mg/m2 divided by standard time to complete treatment in a number of weeks)
Time frame
20 weeks, in case of dose delays up to 30 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
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
Universitair Ziekenhuis Brussel
Collaborator
Centre Hospitalier Universitaire UCLouvain Namur
Collaborator
Centre Hospitalier Universitaire de Liege
Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Collaborator
Source ClinicalTrials.gov