Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase IV Screening Active 25 to 70 Other DBCG07MRBRCA DBCG07MRBRCA, NCT00413491

Trial Description

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.

Further Study Information

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.

Eligibility Criteria

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Danish Breast Cancer Cooperative Group

Ilse Vejborg, MD

Principal Investigator

Ilse Vejborg, MD		Ph: 45-35-451-662
		Email: rh02727@rh.dk

Carsten Conrad, MD
		Email: sve.cgc@nja.dk

Denmark
	Copenhagen
	Rigshospitalet - Copenhagen University Hospital
		Ilse Vejborg, MD	Principal Investigator
	Esbjerg
	Centralsygehus Esbjerg
		Stig M Nielsen, MD	Principal Investigator
	Hjørring
	Sygehus Vendsyssel
		Carsten Conrad, MD	Principal Investigator
	Svendborg
	Sygehus Svendborg
		Leslie Christensen, MD	Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00413491
Information obtained from ClinicalTrials.gov on July 16, 2008