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

Randomized Trail of Breast MRI for Newly Diagnosed Early Stage Breast Cancer: Impact on Re-excision Lumpectomy

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.

Study Overview

• Status: Terminated
• Conditions: Breast Cancer
• Intervention / Treatment: Other: MRI

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 Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana-Farber Cancer Institute
    • Boston, Massachusetts, United States, 02215
      • Brigham and Women's Hospital
    • Boston, Massachusetts, United States, 02215
      • Faulkner Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: MRI	Other: MRI; Breast MRI
No Intervention: No MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess if pre-operative MRI reduces incidence of re-excisions required	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	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Mastectomy Rates	Total Mastectomy Rates	2 years
Number of biopsies	The number of biopsies recommended and performed	2 years
Local-regional recurrence rates	Local-regional recurrence rates in participants undergoing local therapy	2 years
Time from diagnosis to local therapy	The time from diagnosis to definitive local therapy	2 years
Number of malignancies in contralateral breast	The number of malignancies identified int he contralateral breast	2 years

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): March 1, 2013
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: March 29, 2012
• First Submitted That Met QC Criteria: March 30, 2012
• First Posted (Estimate): April 2, 2012

Study Record Updates

• Last Update Posted (Estimate): August 2, 2016
• Last Update Submitted That Met QC Criteria: August 1, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Newly diagnosed; Early stage
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 11-330

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No