A Randomized Controlled Trial of Routine Shave Margins Versus Standard Partial Mastectomy in Breast Cancer Patients

Breast Cancer Clinical Trial

Official title:

A Randomized Controlled Trial of Routine Shave Margins vs. Standard Partial Mastectomy in Breast Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01452399
• Other study ID #: 1107008825
• Status: Completed
• Phase: N/A
• Start date: October 2011
• Est. completion date: August 2020

Study information

• Verified date: January 2021
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This research study is designed to look at whether the routine use of shave margins (by taking extra tissue at the time of partial mastectomy surgery) will reduce the chances of having positive surgical margins requiring another surgical procedure, and whether this affects the long-term chances of getting cancer back in your breast.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 251
• Est. completion date: August 2020
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

1. Breast cancer, stage 0-3, deemed a surgically appropriate candidate for partial mastectomy with planned procedure for the same.

2. Women = 18 years of age.

3. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

1. Patients who have received previous neoadjuvant chemotherapy

2. Patients who require a total mastectomy

3. Known metastatic breast cancer.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• Shave margins
Partial mastectomy with shave margins.
• No Shave Margins
Partial mastectomy without shave margins.

Locations

Country	Name	City	State
United States	Yale University School of Medicine	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Optimal surgical treatment	To determine whether routine shave margins in breast cancer patients undergoing partial mastectomy will result in more optimal surgical treatment of breast cancer patients, as defined by reduced positive margin rates	12 months
Secondary	Cosmesis	To determine the effect of routine shave margins on cosmesis	12 months
Secondary	Operative time	To determine the effect of routine shave margins on the time in the operating suite.	12 months
Secondary	Volume of tissue resected	To determine the effect of routine shave margins on the volume of tissue resected.	12 months