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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
EU CTIS ID: 2023-503994-39-00
What this study is testing
The main aim is to verify whether Low Dose Tamoxifen (LDT) increases circulating Sex Hormone Binding Globulin (SHBG) more than lifestyle intervention (LI) with or without intermittent caloric restriction (ICR) after 6 months of intervention
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 bilateral mammogram within 12 months before baseline visit is required. The diagnostic mammogram (i.e. before breast surgery) is acceptable
You likely can't join if
- 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)
See the full eligibility 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 bilateral mammogram within 12 months before baseline visit is required. The diagnostic mammogram (i.e. before breast surgery) is acceptable
- 6. A negative transvaginal ultrasound/hysteroscopy within 6 months before baseline visit. Women with a previous hysterectomy due to a benign condition, are not required a transvaginal ultrasound.
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.