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

Study Overview
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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).

Official Title
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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

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

Intervention / Treatment
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* Procedure: Remove tumor only
* Procedure: Removal of tumor and tissue


Participation Criteria
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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 Exclusion Criteria: Stage IV breast cancers

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparing 2 surgical methods for treatment of early stage breast cancer | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Tumors or cancer of the human breast, Breast Tumors, Cancer of Breast, Cancer of the Breast, Human Mammary Carcinoma, Neoplasms, Breast