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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2015-02-28

Brief Summary

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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).

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Detailed Description

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Conditions

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Breast Neoplasms Breast Cancer Breast Tumors Cancer of Breast Cancer of the Breast Human Mammary Carcinoma Neoplasms, Breast

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Breast Conserving Surgery (BCS)

Group Type ACTIVE_COMPARATOR

Remove tumor only

Intervention Type PROCEDURE

No additional margins (tissue) removed at the initial surgery

Breast Conserving Surgery with Additional 5 Margins (BCS + M)

Group Type ACTIVE_COMPARATOR

Removal of tumor and tissue

Intervention Type PROCEDURE

5 additional margins (tissue) removed at the time of surgery

Interventions

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Remove tumor only

No additional margins (tissue) removed at the initial surgery

Intervention Type PROCEDURE

Removal of tumor and tissue

5 additional margins (tissue) removed at the time of surgery

Intervention Type PROCEDURE

Eligibility Criteria

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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