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

January 25, 2021 updated by: Yale University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

251

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale University School Of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Shave Margins
Procedure: Shave margins
Partial mastectomy with shave margins.
ACTIVE_COMPARATOR: No shave margins
Procedure: No Shave Margins
Partial mastectomy without shave margins.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Optimal surgical treatment
Time Frame: 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
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cosmesis
Time Frame: 12 months
To determine the effect of routine shave margins on cosmesis
12 months
Operative time
Time Frame: 12 months
To determine the effect of routine shave margins on the time in the operating suite.
12 months
Volume of tissue resected
Time Frame: 12 months
To determine the effect of routine shave margins on the volume of tissue resected.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Investigators

  • Principal Investigator: Anees Chagpar, M.D., The Breast Center -- Smilow Cancer Hospital at Yale-New Haven

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2011

Primary Completion (ACTUAL)

August 1, 2014

Study Completion (ACTUAL)

August 1, 2020

Study Registration Dates

First Submitted

September 29, 2011

First Submitted That Met QC Criteria

October 11, 2011

First Posted (ESTIMATE)

October 14, 2011

Study Record Updates

Last Update Posted (ACTUAL)

January 26, 2021

Last Update Submitted That Met QC Criteria

January 25, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1107008825

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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