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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01568346
• Other study ID #: 11-330
• Status: Terminated
• Phase: Phase 3
• First received: March 29, 2012
• Last updated: August 1, 2016
• Start date: February 2012
• Est. completion date: March 2013

Study information

• Verified date: August 2016
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• MRI
Breast MRI

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Faulkner Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Total Mastectomy Rates	Total Mastectomy Rates	2 years	No
Secondary	Number of biopsies	The number of biopsies recommended and performed	2 years	No
Secondary	Local-regional recurrence rates	Local-regional recurrence rates in participants undergoing local therapy	2 years	No
Secondary	Time from diagnosis to local therapy	The time from diagnosis to definitive local therapy	2 years	No
Secondary	Number of malignancies in contralateral breast	The number of malignancies identified int he contralateral breast	2 years	No