A Randomized Controlled Trial of Routine Shave Margins Versus Standard Partial Mastectomy in Breast Cancer Patients
This research study is designed to look at whether the routine use of shave margins (by taking extra tissue at the time of partial mastectomy surgery) will reduce the chances of having positive surgical margins requiring another surgical procedure, and whether this affects the long-term chances of getting cancer back in your breast.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized Controlled Trial of Routine Shave Margins vs. Standard Partial Mastectomy in Breast Cancer Patients|
- Optimal surgical treatment [ Time Frame: 12 months ] [ Designated as safety issue: No ]To determine whether routine shave margins in breast cancer patients undergoing partial mastectomy will result in more optimal surgical treatment of breast cancer patients, as defined by reduced positive margin rates
- Cosmesis [ Time Frame: 12 months ] [ Designated as safety issue: No ]To determine the effect of routine shave margins on cosmesis
- Operative time [ Time Frame: 12 months ] [ Designated as safety issue: No ]To determine the effect of routine shave margins on the time in the operating suite.
- Volume of tissue resected [ Time Frame: 12 months ] [ Designated as safety issue: No ]To determine the effect of routine shave margins on the volume of tissue resected.
|Study Start Date:||October 2011|
|Estimated Study Completion Date:||October 2016|
|Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
|Experimental: Shave Margins||
Procedure: Shave margins
Partial mastectomy with shave margins.
|Active Comparator: No shave margins||
Procedure: No Shave Margins
Partial mastectomy without shave margins.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01452399
|United States, Connecticut|
|Yale University School of Medicine|
|New Haven, Connecticut, United States, 06510|
|Principal Investigator:||Anees Chagpar, M.D.||The Breast Center -- Smilow Cancer Hospital at Yale-New Haven|