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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Emory University
- 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)
Intervention: Removal of tumor and tissue (Procedure)
Breast Conserving Surgery (BCS)
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
Monica Rizzo
Principal Investigator
Emory University
