Breast MRI for Newly Diagnosed Breast Cancer:Impact on Re-excision Lumpectomy

Phase 3

Terminated

• Conditions: Breast Cancer
• Interventions: Other: MRI

• Registration Number: NCT01568346
• Lead Sponsor: Dana-Farber Cancer Institute

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.

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-03-29
• Study First Submitted QC: 2012-03-30
• Study First Posted: 2012-04-02
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-01
• Last Update Posted: 2016-08-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 9

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MRI	MRI	MRI

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Number of malignancies in contralateral breast	2 years	The number of malignancies identified int he contralateral breast
Time from diagnosis to local therapy	2 years	The time from diagnosis to definitive local therapy

Trial Locations

Locations (3)

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Faulkner Hospital; 🇺🇸 Boston, Massachusetts, United States