Breast Cancer, Neoplasm Mammae, Screening, MRI, Mammography, Breast Density Borst kanker, Neoplasma Mammae, Screening, MRI, mammografie, borstdensiteit
Conditions
Interventions
1. MRI with clinical examination yearly + mammography every other year (year 1 + 3) (n=1000
2. Mammography with clinical examination yearly (n=1000).
Sponsors
Erasmus MC, Daniel den Hoed Clinic, Faculty of Medicine, Department of Surgical Oncology
Eligibility
Inclusion criteria
Inclusion criteria: 1. Cumulative Life Time Risk ≥20%, defined by Claus Adjusted Tables; 2. Age at inclusion 30-55 years, or 5 years younger than youngest case of breast cancer in family; 3. Willing to provide informed consent.
Exclusion criteria
Exclusion criteria: 1. Personal history of invasive (breast) cancer, except for basal cell carcinoma; 2. Having a (50% risk of a) known BRCA1, BRCA2 or P53 mutation; 3. Breast MRI contra-indications like kidney dysfunction or metal implantation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The number of tumours detected at screening examinations and in between screening examinations (interval tumours), and the stage distribution at diagnosis in the different trial arms. The results will also be analyzed by density score. | — |
Secondary
| Measure | Time frame |
|---|---|
| Sensitivity, proportion of false-positive results and specificity of MRI and mammography in both arms. Furthermore breast cancer mortality reduction will be estimated using breast cancer microsimulation models (MISCAN). Cost effectiveness analyses will be performed. Costs will be calculated per quality adjusted life-year gained. | — |
Contacts
Public ContactS. Saadatmand
Erasmus MC, Daniel den Hoed Clinic, Faculty of Medicine, Department of Surgical Oncology, Groene Hilledijk 301
Outcome results
None listed