NCT01271738

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 79 (actual)
• Sponsor: Emory University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

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

Interventions

Type	Name	Description
PROCEDURE	Remove tumor only	No additional margins (tissue) removed at the initial surgery
PROCEDURE	Removal of tumor and tissue	5 additional margins (tissue) removed at the time of surgery

Timeline

• Start date: 2009-09-01
• Primary completion: 2015-02-01
• Completion: 2015-02-01
• First posted: 2011-01-07
• Last updated: 2015-08-17

Locations

1 site across 1 country: United States