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

Yale University

Status: Completed

Conditions: Breast Cancer

Treatments: Procedure: Shave margins; Procedure: No Shave Margins

Study type: Interventional

Funder types: Other

Identifiers

NCT01452399

1107008825

Details and patient eligibility

About

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.

Enrollment: 251 patients

Sex: Female

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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251 participants in 2 patient groups

Shave Margins

Experimental group

Treatment:

Procedure: Shave margins

No shave margins

Active Comparator group

Treatment:

Procedure: No Shave Margins