Low Dose TamOxifen and LifestylE Changes for bReast cANcer prevenTion

Launched by EUROPEAN INSTITUTE OF ONCOLOGY · Sep 11, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating whether a low dose of tamoxifen (a medication often used to prevent breast cancer) can help increase levels of a protein called Sex Hormone Binding Globulin (SHBG) in women who are at a higher risk of developing breast cancer. The study also looks at how lifestyle changes, including diet and exercise, might affect SHBG and other health markers. Participants will include women aged 18 to 70 who carry specific genetic mutations linked to breast cancer risk or have had certain breast health issues in the past.

If eligible, participants can expect to take part in this 6-month study, where they may receive either the low dose tamoxifen, engage in lifestyle interventions, or both. They will be monitored for changes in various health markers and their quality of life. It’s important to note that women who are pregnant, have had certain treatments for breast cancer, or have specific health conditions may not qualify for this trial. This study aims to provide valuable insights into breast cancer prevention strategies for women at risk.

Gender

FEMALE

Eligibility criteria

• 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% breast cancer 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. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1;
• • 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 invasive breast cancer;
• • 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 and 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.
• • 10. No hormonal contraception is allowed during study intervention. Non-hormonal methods will be advised for women of childbearing potential (WOCBP)