Low Dose Tamoxifen and Lifestyle Changes for Breast Cancer Prevention (TOLERANT Study)
Study Overview
The TOLERANT study aims to evaluate the impact of different interventions, including low-dose tamoxifen (LDT), intermittent caloric restriction (ICR), lifestyle intervention (LI), and their combinations on biomarkers associated with breast cancer risk in high-risk women.
Study Design
Unaffected women aged 18-70 with a genetic predisposition to breast cancer or a >5% 10-year risk of developing breast cancer are eligible to participate. The study will be conducted in 4 Italian centers, with 200 participants randomized into one of the four arms: LDT; LDT + ICR; LI; LI + ICR. The interventions will span six months, with baseline and follow-up clinic visits and interim phone calls.
Objectives
The primary objective is to determine whether LDT increases circulating Sex Hormone Binding Globulin (SHBG) more than LI with or without ICR after 6 months. Secondary objectives include assessing other biomarkers, quality of life, safety, toxicity, mammographic density, and changes in microbiome composition across groups.
Significance
The study’s innovative approach includes diverse breast cancer risk categories and a combination of pharmaceutical and behavioral interventions, potentially enhancing intervention efficacy while managing tamoxifen’s side effects on quality of life, especially menopausal symptoms.
Trial Registration
EuCT number: 2023-503994-39-00; ClinicalTrials.gov NCT06033092
