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

Not Applicable

Completed

• Conditions: Breast Tumors; Cancer of Breast; Neoplasms, Breast; Breast Cancer; Cancer of the Breast; Human Mammary Carcinoma; Breast Neoplasms
• Interventions: Procedure: Remove tumor only; Procedure: Removal of tumor and tissue

• Registration Number: NCT01271738
• Lead Sponsor: Emory University

Brief Summary

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).

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 Start: 2009-09
• Study First Submitted: 2010-12-06
• Study First Submitted QC: 2011-01-06
• Study First Posted: 2011-01-07
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-13
• Last Update Posted: 2015-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 79

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

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Exclusion Criteria

• Stage IV breast cancers

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Breast Conserving Surgery (BCS)	Remove tumor only	-
Breast Conserving Surgery with Additional 5 Margins (BCS + M)	Removal of tumor and tissue	-

Primary Outcome Measures

Name	Time	Method
Comparing 2 surgical methods for treatment of early stage breast cancer	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.

Trial Locations

Locations (1)

Emory University Winship Cancer Institute; 🇺🇸 Atlanta, Georgia, United States