Clinical trial NCT00413491: National Screening in Denmark With MR Versus Mammography and Ultrasound of Women With BRCA1 or BRCA2 Mutations
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Breast Cancer
Keywords: Breast Cancer
BRCA1 gene
BRCA2 gene
Magnetic Resonance Imaging
Mammography
Ultrasonography
Lead sponsor: Danish Breast Cancer Cooperative Group
Sponsor class: OTHER
First posted: 2006-12-19
Enrollment: 300
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief 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.

Detailed 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.

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

Primary outcomes:
measure: 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.
timeFrame: 3 years
Secondary outcomes:
measure: Comparison of diagnostic outcome of MR versus combined mammography and ultrasound, in women with dense breast tissue compared with women with fatty breast tissue.
timeFrame: 3 years
measure: 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.
timeFrame: 3 years
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Radiology,Copenhagen University Hospital Rigshospitalet
city: Esbjerg
country: Denmark
facility: Department of Radiology, Esbjerg Sygehus
city: Hjørring
country: Denmark
facility: Department of Radiology, Sygehus Vendsyssel
city: Svendborg
country: Denmark
facility: Department of Radiology, Svendborg Sygehus
Study officials:
affiliation: Danish Breast Cancer Cooperative Group
name: Ilse Vejborg, MD
role: PRINCIPAL_INVESTIGATOR
References: