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

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Procedure: Shave margins; Procedure: No Shave Margins

• Registration Number: NCT01452399
• Lead Sponsor: Yale University

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2011-09-29
• Study Start: 2011-10
• Study First Submitted QC: 2011-10-11
• Study First Posted: 2011-10-14
• Primary Completion: 2014-08
• Study Completion: 2020-08
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-25
• Last Update Posted: 2021-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 251

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.

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Exclusion Criteria

1. Patients who have received previous neoadjuvant chemotherapy
2. Patients who require a total mastectomy
3. Known metastatic breast cancer.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Shave Margins	Shave margins	-
No shave margins	No Shave Margins	-

Primary Outcome Measures

Name	Time	Method
Optimal surgical treatment	12 months	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

Secondary Outcome Measures

Name	Time	Method
Cosmesis	12 months	To determine the effect of routine shave margins on cosmesis
Operative time	12 months	To determine the effect of routine shave margins on the time in the operating suite.
Volume of tissue resected	12 months	To determine the effect of routine shave margins on the volume of tissue resected.

Trial Locations

Locations (1)

Yale University School of Medicine; 🇺🇸 New Haven, Connecticut, United States