Clinical trial NCT01568346: Breast MRI for Newly Diagnosed Breast Cancer:Impact on Re-excision Lumpectomy
Official title: Randomized Trail of Breast MRI for Newly Diagnosed Early Stage Breast Cancer: Impact on Re-excision Lumpectomy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Breast Cancer
Keywords: Newly diagnosed
Early stage
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2012-04-02
Enrollment: 9
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study is being done to find out the number of surgical procedures required to achieve clear margins in women with newly diagnosed early stage breast carcinoma. The investigators are also looking at the number of additional biopsies performed before surgery, the mastectomy rate, detection of breast cancer on the opposite side (contralateral carcinoma), time form diagnosis to local therapy, and evaluation time to local recurrence.

Detailed description: This is a prospective pragmatic trial randomizing women diagnosed with early stage breast cancer to MRI versus no breast MRI. Data analyzed will include medical record information abstracted from the clinical records. Date and modality of all imaging performed, malignancy(s) identified, abnormalities identified, image guided procedures performed, surgical procedures performed and pathology results.

The primary aim of this study is to assess if the use of pre-operative MRI can reduce the incidence of re-excisions required to achieve clear margins in women with newly diagnosed early stage breast carcinoma.

Eligibility criteria: Inclusion Criteria:

* Must undergo definitive local therapy with either breast conserving therapy or mastectomy
* Clinical Stage 0, I or II breast cancer based on examination and/or conventional imaging of mammogram with or without ultrasound. Tumors must be less than 5 cm in size and the patient clinically node negative
* Able to undergo breast MRI

Exclusion Criteria:

* Not pregnant or breastfeeding
* No prior breast MRI for the newly diagnosed carcinoma at the outside hospital
* No prior mantle radiation
* No locally advanced breast cancer
* No diffuse malignant appearing microcalcifications requiring mastectomy
* No known collagen vascular disease
* No previous ipsilateral radiation
* No participants who undergo surgery at an outside institution
* No prior history of breast carcinoma

Primary outcomes:
measure: Assess if pre-operative MRI reduces incidence of re-excisions required
timeFrame: 2 years
Secondary outcomes:
measure: Total Mastectomy Rates
timeFrame: 2 years
measure: Number of biopsies
timeFrame: 2 years
measure: Local-regional recurrence rates
timeFrame: 2 years
measure: Time from diagnosis to local therapy
timeFrame: 2 years
measure: Number of malignancies in contralateral breast
timeFrame: 2 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Boston
country: United States
facility: Faulkner Hospital
state: Massachusetts
Study officials:
References: