Evaluating and Comparing Two Surgical Methods for Treatment of Early Stage Breast Cancer

August 13, 2015 updated by: Monica Rizzo, Emory University

Measuring the Effect of Additional Tumor Cavity Margins Excision at the Time of Breast Conserving Surgery for Stage 0, I, II, and III Breast Cancer Patients on Re-excision Rate, Cosmetic Results and Total Costs

The goal of this study is to compare two different types of breast surgery. In the first type, the doctor removes only the tumor. In the second type, the doctor removes the tumor and some of the tissue around the tumor called margins. The amount of breast tissue removed is similar. The removal of the tumor only has up to 40% chance of reoperation because the tumor is too close to the margin. The primary goal of this study is to see if the additional margins can decrease the need to return to the operating room. Both types of surgery are well accepted, and participating in the study would not give you a better chance to cure the cancer. At present, most breast surgeons remove the tumor without the additional margins. For all patients who have this operation, there is a high incidence of return to the operating room for margins re-excision: as many as 40% as patients can have a re-operation.

At present, we do not know if taking the additional margins prevents the cancer from returning in the breast or not. If the cancer comes back in your breast, this is a recurrence and your breast will have to be removed (mastectomy).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

79

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
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University Winship Cancer Institute

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female Patients with the diagnosis of Stage 0, I, II and III breast cancer diagnosed/treated at the AVON Foundation Comprehensive Breast Center (AFCBC) of Grady Memorial Hospital
  • Age: no limit

Exclusion Criteria:

  • Stage IV breast cancers

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Breast Conserving Surgery (BCS)
Procedure: Remove tumor only
No additional margins (tissue) removed at the initial surgery
Active Comparator: Breast Conserving Surgery with Additional 5 Margins (BCS + M)
Procedure: Removal of tumor and tissue
5 additional margins (tissue) removed at the time of surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparing 2 surgical methods for treatment of early stage breast cancer
Time Frame: Post operative evaluation will be at 30 days, then at 4-7 months and last at 12-15 months.
The investigator will survey patients with the cosmetic assessment survey after the surgical procedure.
Post operative evaluation will be at 30 days, then at 4-7 months and last at 12-15 months.

Collaborators and Investigators

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

Sponsor

Emory University

Investigators

  • Principal Investigator: Monica Rizzo, MD, EmoryUniversity Winship Cancer Institute

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

September 1, 2009

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

December 6, 2010

First Submitted That Met QC Criteria

January 6, 2011

First Posted (Estimate)

January 7, 2011

Study Record Updates

Last Update Posted (Estimate)

August 17, 2015

Last Update Submitted That Met QC Criteria

August 13, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00013658
  • WCI1659-09 (Other Identifier: Other)

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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