Breast cancer prevention in women at increased risk using low dose tamoxifen and/or diet and life style changes: a randomized 4 arms clinical study

Phase 1

Recruiting

Conditions: Therapeutic area: Diseases [C] - Neoplasms [C04]
Healthy women aged 18-70 either carriers of a germline pathogenetic variant (BRCA1, BRCA2, PALB2, ATM, CHEK2, CDH1, 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 (intraepithelialneoplasia).
MedDRA version: 21.1Level: PTClassification code: 10006189Term: Breast cancer in situ Class: 100000004864
MedDRA version: 21.1Level: LLTClassification code: 10022779Term: Intraductal breast cancer (in situ) Class: 10029104

Registration Number: CTIS2023-503994-39-00

Lead Sponsor: European Institute Of Oncology S.r.l.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 200

Inclusion Criteria

1.Women between 18 and 70 years old, 2.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 > 5% BC risk at 10 years, using the Tyrer Cuzick or the Breast Cancer Surveillance Consortium Risk models, or with previous diagnosis of intraepithelial neoplasia (surgery for ADH, LCIS, ER positive DCIS) within the last 3 years, 3.Ability to understand and the willingness to sign a written informed consent document., 4.ECOG performance status =1 (Karnofsky =70%), 5a.For high risk strata: A negative mammogram or any radiological image based on age and center protocol screening within 6 months before baseline visit, 5b.For IEN Strata: A negative mammogram within 12 months before baseline visit, 6. A negative transvaginal ultrasound within 6 months before baseline visit

Exclusion Criteria

1.Diagnosis of ER negative (<10%) DCIS, or history of breast invasive cancer, 10. No hormonal contraception is allowed during study intervention. Non-hormonal methods will be advised for women of childbearing potential (WOCBP)., 2.Previous treatment with SERMs or any other hormonal treatment for breast neoplasms, 3.BMI < 18.5 Kg/m2 and/or Malnutrition Universal Screening Tool (MUST) score =2 and/or any current or past eating disorders, 4.Any diagnosis of invasive neoplasia, except non-melanoma skin cancer, in the previous 5 years, 5.Any tamoxifen contraindications (abnormal liver function, previous ischemic heart disease, endometrial disorder, previous deep venous thrombosis, history of pulmonary embolus, current or suspected glaucoma, retinopathy or cataract), 6. Current use of warfarin or other anticoagulant drugs, 7. Bilateral mastectomy, 8. Pregnancy or desire to become pregnant in the subsequent 9 months after treatment cessation, 9. Diabetes or any other clinical condition that at the investigator’s discretion contraindicates the proposed intervention