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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01271738
• Other study ID #: IRB00013658
• Secondary ID: WCI1659-09
• Status: Completed
• Phase: N/A
• First received: December 6, 2010
• Last updated: August 13, 2015
• Start date: September 2009
• Est. completion date: February 2015

Study information

• Verified date: August 2015
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Remove tumor only
No additional margins (tissue) removed at the initial surgery
• Removal of tumor and tissue
5 additional margins (tissue) removed at the time of surgery

Locations

Country	Name	City	State
United States	Emory University Winship Cancer Institute	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes