Breast Cancer
Conditions
Keywords
Newly diagnosed, Early stage
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.
Interventions
OTHERMRI
Breast MRI
Sponsors
Dana-Farber Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess if pre-operative MRI reduces incidence of re-excisions required | 2 years | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Mastectomy Rates | 2 years | Total Mastectomy Rates |
| Number of biopsies | 2 years | The number of biopsies recommended and performed |
| Local-regional recurrence rates | 2 years | Local-regional recurrence rates in participants undergoing local therapy |
| Time from diagnosis to local therapy | 2 years | The time from diagnosis to definitive local therapy |
| Number of malignancies in contralateral breast | 2 years | The number of malignancies identified int he contralateral breast |
Countries
United States
Outcome results
None listed