ATM, BRCA2, CDH1, CHEK2, Healthy women aged 18-70 either carriers of a germline pathogenetic variant (BRCA1, PALB2, RAD51C or RAD51D) or with a breast cancer risk >5% at 10 years (according to the Tyrer-Cuzick model or the Breast Cancer Surveillance Consortium Risk models) or with a previously treated breast IEN (intraepithelial neoplasia).
Conditions
Brief summary
Post intervention levels of circulating Sex Hormone Binding Globulin (SHBG)
Detailed description
Changes in time of serum biomarkers: SHBG, insulin, glucose, lipid profile, IGF-I, IGFBP-1, -2 and -3, hs-CRP, adiponectin and leptin;, Changes in time of safety and toxicity, Changes in time of quality of life, Changes in time of BMI and body composition, Changes in time of microbiome composition, Changes in time of immune modulation by expression of inflammation cell signaling genes
Interventions
DRUGNolvadex 10 mg compresse rivestite con film
Sponsors
Istituto Europeo Di Oncologia S.r.l.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Post intervention levels of circulating Sex Hormone Binding Globulin (SHBG) | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in time of serum biomarkers: SHBG, insulin, glucose, lipid profile, IGF-I, IGFBP-1, -2 and -3, hs-CRP, adiponectin and leptin;, Changes in time of safety and toxicity, Changes in time of quality of life, Changes in time of BMI and body composition, Changes in time of microbiome composition, Changes in time of immune modulation by expression of inflammation cell signaling genes | — |
Countries
Italy
Outcome results
None listed