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Clinical Trials/NCT01271738
NCT01271738CompletedNot Applicable

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

Emory University1 site in 1 country79 target enrollmentStarted: September 1, 2009Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
79
Locations
1
Primary Endpoint
Comparing 2 surgical methods for treatment of early stage breast cancer

Study Overview

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).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

Arms & Interventions

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

Active Comparator

Intervention: Removal of tumor and tissue (Procedure)

Breast Conserving Surgery (BCS)

Active Comparator

Intervention: Remove tumor only (Procedure)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Monica Rizzo

Principal Investigator

Emory University

Study Sites (1)

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