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

Launched by UNIVERSITAIRE ZIEKENHUIZEN KU LEUVEN · Feb 12, 2025

Keywords

ClinConnect Summary

The clinical trial titled "LifEStyle Intervention to Enhance Efficacy of Neoadjuvant Therapy in Patients with Triple Negative Breast Cancer" aims to explore whether combining a special diet that mimics fasting with exercise can help improve the effectiveness of treatment for patients with triple negative breast cancer (TNBC). This trial is designed for patients who are about to start chemotherapy or immunotherapy before surgery, known as neoadjuvant therapy. Researchers believe that this lifestyle change could not only enhance how well the treatment works but also help patients tolerate the treatment better and improve their overall quality of life.

To be eligible for this trial, participants need to have a confirmed diagnosis of stage II or III TNBC and must meet certain health criteria, such as being able to perform a specific exercise test and having a healthy body weight. The trial is open to all genders and is not yet recruiting participants. Those who join will have the chance to follow a guided diet and exercise plan while receiving their cancer treatment. This study could provide valuable insights into how lifestyle changes can impact cancer care.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • The patient has a biopsy-confirmed diagnosis of stage II-III TNBC
• • 1. Patients with tumor stage T1cN1-2, T2N0-N2, T3N0-N2, T4N0-N2
• • 2. 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
• • 3. 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%
• Exclusion Criteria:
• * had a treatment with any of the following:
• • 1. any other chemotherapy, immunotherapy or anticancer agents within 5 years of the first dose of study treatment
• • 2. 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
• • 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 (HIV). Screening for chronic conditions is not required
• • 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)