Status:
ACTIVE_NOT_RECRUITING
Low Dose TamOxifen and LifestylE Changes for bReast cANcer prevenTion
Lead Sponsor:
European Institute of Oncology
Collaborating Sponsors:
Ente Ospedaliero Ospedali Galliera
Istituto Oncologico Veneto IRCCS
Conditions:
BRCA Mutation
PALB2 Gene Mutation
Eligibility:
FEMALE
18-70 years
Phase:
PHASE2
Brief Summary
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 Tamoxi...
Detailed Description
Italian, multicenter, phase II, biomarker trial. A total of 200 women aged 18-70 years will be randomly assigned (1:1:1:1) to one of the four intervention arms Arm 1: Low dose Tamoxifen (LDT) i.e. 10 ...
Eligibility Criteria
Inclusion
- Women between 18 and 70 years old;
- 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;
- Ability to understand and the willingness to sign a written informed consent document;
- 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
- Diagnosis of ER-negative (\<10%) DCIS, or history of invasive breast cancer;
- Previous treatment with SERMs or any other hormonal treatment for breast neoplasms;
- BMI \< 18.5 Kg/m2 and/or Malnutrition Universal Screening Tool (MUST) score ≥2 and/or any current or past eating disorders;
- Any diagnosis of invasive neoplasia, except non-melanoma skin cancer, in the previous 5 years;
- 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);
- Current use of warfarin or other anticoagulant drugs
- Bilateral mastectomy;
- Pregnancy or desire to become pregnant in the subsequent 9 months after treatment cessation;
- Diabetes or any other clinical condition that at the investigator's discretion contraindicates the proposed intervention.
- No hormonal contraception is allowed during study intervention. Non-hormonal methods will be advised for women of childbearing potential (WOCBP)
Key Trial Info
Start Date :
June 21 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06033092
Start Date
June 21 2024
End Date
January 1 2026
Last Update
August 28 2025
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
E.O. Galliera
Genoa, Italy
2
Istituto Europeo di Oncologia
Milan, Italy, 20141
3
Istituto Nazionale Tumori G. Pascale
Napoli, Italy
4
Istituto Oncologico Veneto
Padua, Italy