Phase 2Completed
Low Dose TamOxifen and LifestylE Changes for bReast cANcer prevenTion (TOLERANT)
Low Dose TamOxifen and LifestylE Changes for bReast cANcer prevenTion: a Randomized Phase II Biomarker Trial in Subjects at Increased Risk
- Sponsor
- European Institute of Oncology (Academic or other)
- Enrollment
- 110 enrolled
- Conditions
- BRCA Mutation; PALB2 Gene Mutation; Ductal Carcinoma in Situ; Lobular Carcinoma in Situ; ATM Gene Mutation; CHEK2 Gene Mutation; CDH1 Gene Mutation; RAD51C Gene Mutation; RAD51D Gene Mutation
- Interventions
- Tamoxifen 10 mg Tablet; Intermittent caloric restriction; Step counter Device
- Ages
- adults, older adults
- Registry
- NCT06033092, CTIS2023-503994-39-00
Full record on ClinicalTrials.gov
From the registry
Circulating levels of Sex Hormone Binding Globulin (SHBG) are significantly associated with a decreased risk of breast cancer. The main aim of this clinical trial is to verify whether Low Dose Tamoxifen (LDT) increases circulating levels of SHBG more than lifestyle intervention (LI) with or without intermittent caloric restriction (ICR) after 6 months in women at increased risk of breast cancer (i.e., healthy participants carriers of a germline pathogenic/likely pathogenetic variant in at least one of the following genes: BRCA1, BRCA2, PALB2, ATM, CHEK2, CDH1, RAD51C or RAD51D, or with \> 5% breast cancer risk at 10 years, using the Tyrer Cuzick or the Breast Cancer Surveillance Consortium Risk models or with a recently resected intraepithelial neoplasia of the breast (IEN). The secondary aims are: * to verify whether ICR significantly modulates primary and secondary endpoints such as Homeostasis Model Assessment (HOMA) index, immune and inflammatory markers, lipid profile, Adiponectin/Leptin (A/L) ratio, quality of life (QoL), Body mass index (BMI), fat body composition, safety…
Primary outcomes
- Post intervention levels of circulating binding globulin
History
Last registry update
Study completion
Primary completion
Started
Registered