National Screening in Denmark With MR Versus Mammography and Ultrasound of Women With BRCA1 or BRCA2 Mutations

Breast Cancer Clinical Trial

— MR BRCA  

Official title:

National Screening i Danmark Med MR-scanning af Brystet Kontra Klinisk Mammografi Hos Kvinder Der er bærere af Risikogivende BRCA1 Eller BRCA2 Mutationer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00413491
• Other study ID #: DBCG07MRBRCA
• Secondary ID: DBCG07MRBRCA
• Status: Recruiting
• Phase: Phase 4
• First received: December 14, 2006
• Last updated: May 19, 2014
• Start date: January 2007
• Est. completion date: June 2015

Study information

• Verified date: January 2009
• Source: Danish Breast Cancer Cooperative Group
• Contact: Ilse Vejborg, MD
• Phone: 45-35-451-662
• Email: Ilse.Vejborg[@]regionh.dk
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to determine whether MR of the breast is a better screening tool than mammography combined with ultrasound of the breast in women with BRCA1 or BRCA2 gene mutations.

Description:

Study type : Interventional Study design: Diagnostic,Prospective,Non Randomised,Blinded,Efficacy study

Further study details as provided by DBCG ( Danish Breast Cancer Cooperative Group):

Primary outcome measures:

Diagnostic outcome of a yearly screening with MR versus combined mammography and ultrasound of the breast measured by accuracy, sensitivity, specificity, positive and negative predictive values.

Secondary outcome measures:

Comparison of diagnostic outcome of MR versus combined mammography and ultrasound, in women with dense breast tissue compared with women with fatty breast tissue.

Comparison of the cancers found in women with BRCA gene mutations compared with the cancers found in the background population in respect of morphology, size, histological type, axillary lymph node status and grade.

Study start : January 2007. Expected completion 2010.

Women with BRCA gene mutations are more likely than others to develop the disease at a young age when breast density is higher than at older age.The tumours often are more rapidly developing with a short presymptomatic phase. These factors are known to reduce the effectiveness of screening with mammography and mammography seems to have a low sensitivity in women with BRCA gene mutations. Other studies have shown that more than 50% of the cancers appears as interval cancers between two mammography screening examinations and many have positive axillary nodes at the time of diagnosis.

Around 610 women are tested BRCA gene positive in Denmark in year 2006. These women are offered a yearly screening with mammography combined with ultrasound and a clinical examination. The trial will test whether this screening offer should be combined with or replaced by MR mammography.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 70 Years

Eligibility

Inclusion Criteria:

• women tested positive of BRCA1 or BRCA2 gene mutations

• referred for screening

• aged 25 - 70 years

Exclusion Criteria:

• general contraindications for MR

• pregnant or lactating

• men

• bilateral mastectomy

• ongoing treatment with chemotherapy

• metastatic breast cancer

• previous breast surgery less than 6 months before MR

• previous radiation therapy of the breast less than 1 year before

• incapable of managing her own affairs

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Screening

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Procedure:
• MR mammography
MR mammography
• MR
MR

Locations

Country	Name	City	State
Denmark	Department of Radiology,Copenhagen University Hospital Rigshospitalet	Copenhagen
Denmark	Department of Radiology, Esbjerg Sygehus	Esbjerg
Denmark	Department of Radiology, Sygehus Vendsyssel	Hjørring
Denmark	Department of Radiology, Svendborg Sygehus	Svendborg

Sponsors (1)

Lead Sponsor	Collaborator
Danish Breast Cancer Cooperative Group

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic outcome of a yearly screening with MR versus combined mammography and ultrasound of the breast measured by accuracy, sensitivity, specificity, positive and negative predictive values.		3 years
Secondary	Comparison of diagnostic outcome of MR versus combined mammography and ultrasound, in women with dense breast tissue compared with women with fatty breast tissue.		3 years
Secondary	Comparison of the cancers found in women with BRCA gene mutations compared with the cancers found in the background population in respect of morphology, size, histological type, axillary lymph node status and grade.		3 years