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Tests treatment safety and results for Triple Negative Breast Cancer (TNBC), Early Setting
Official title LifEStyle Intervention to Enhance Efficacy of Neoadjuvant Therapy in Patients With Triple Negative Breast Cancer
ClinicalTrials.gov ID: NCT06831955
What this study is testing
What is SOC?
SOC is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for triple negative breast cancer (tnbc), early setting.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 21 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- All histological subtypes are eligible, including but not limited to invasive breast cancer of no special type (NST) , invasive lobular carcinoma...
- WHO/ECOG performance status of grade 0-1
You likely can't join if
- had a treatment with any of the following:
- 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...
- prior systemic treatment for breast cancer or other malignancies within 5 years of treatment enrollment, except for adequately treated basal cell or...
- 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...
- Prior treatment with anthracyclines
See the full 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-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
- WHO/ECOG performance status of grade 0-1
- The participant is able to perform a CPET test (cardiopulmonary exercise testing)
- Body mass index ≥ 18.5 kg/m²
- Pregnant or breastfeeding women
- Presence of adequate bone marrow and organ function
- HbA1c \<10%
- had a treatment with any of the following:
- 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...
- 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...
- Prior treatment with anthracyclines
- Prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137)
- Has any disorder, which in the Investigator's opinion might jeopardize the participant's safety or compliance with the protocol
- Has, as judged by the investigator, any evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses, or active infection including hepatitis B, hepatitis C, and human immunodeficiency virus...
- Active autoimmune diseases requiring systemic treatments
- Patients with type 1 diabetes mellitus
- History of alcohol use disorder (DSM-5)
- History of eating disorder (DSM-5)
The study team makes the final eligibility decision.
Where it's taking place
- Antwerp, Belgium
- Brussels, Belgium
- Ghent, Belgium
- Hasselt, Belgium
- Kortrijk, Belgium
- Leuven, Belgium
- Liège, Belgium
- Namur, Belgium
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 21 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Antwerp, Belgium; Brussels, Belgium; Ghent, Belgium; Hasselt, Belgium; Kortrijk, Belgium; Leuven, Belgium and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.