Breast Density as Indicator for the Use of Mammography or MRI to Screen Women with Familial Risk for Breast Cancer: a RCT.

Recruiting

• Conditions: breast cancer; neoplasm mammae; 10006291

• Registration Number: NL-OMON43998
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 2000

Inclusion Criteria

Familial cumulative lifetime breastcancer risk of * 20% according to Claus tables (as used by Genetic Centres)
age 30-55 yrs.

Exclusion Criteria

BRCA1 or BRCA2 mutation carrier or 50% risk of being one.
Personal history of breast cancer
Breast MRI contra-indication like metal implant

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcomes are: the numbers of tumours detected at screening examinations<br /><br>and in between screening examinations (interval tumours), and the stage<br /><br>distribution at diagnosis in the different trial arms, with application of<br /><br>density scores for the analyses of results.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Other outcomes are the sensitivities and proportions of false-positive results.<br /><br>Breast cancer mortality reduction will be estimated using breast cancer<br /><br>microsimulation models (MISCAN). Costs will be calculated per quality adjusted<br /><br>life-year gained. </p><br>