Surgery to Remove Sentinel Lymph Nodes With or Without Removing Lymph Nodes in the Armpit in Treating Women With Breast Cancer
RATIONALE: Removing the sentinel lymph nodes and examining them under a microscope may help plan more effective surgery for breast cancer. It is not yet known if surgery to remove the sentinel lymph nodes is more effective with or without removal of the lymph nodes in the armpit in treating breast cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of surgery to remove the sentinel lymph nodes with or without removal of lymph nodes in the armpit in treating women who have breast cancer.
|Breast Cancer||Procedure: conventional surgery Procedure: Sentinel node resection followed by node examination||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized, Phase III Clinical Trial to Compare Sentinel Node Resection to Conventional Axillary Dissection in Clinically Node-Negative Breast Cancer Patients|
- Morbidity as measured by arm edema, sensory neuropathy, and arm function - mobility [ Time Frame: Before and after surgery ]
- Overall Survival as measured by death from any cause. [ Time Frame: Time from surgery to death from any cause ]
- Disease-free Survival as measured by breast cancer recurrence, any second primary cancer, and death from any cause in patients without a prior event. [ Time Frame: Time from surgery to recurrence, second primary, or death ]
- Prognostic value of pathology status of sentinel nodes and nodes obtained from axillary dissection [ Time Frame: At the time of surgery ]
- Pathology investigation of sentinel nodes [ Time Frame: At time of surgery ]
- The percentage of technically successful sentinel node resections as measured by the proportion of patients for whom at least one sentinel node is identified. [ Time Frame: At time of surgery ]
- Sensitivity of the sentinel node to determine presence of nodal metastases. [ Time Frame: At time of surgery ]
|Study Start Date:||May 1999|
|Study Completion Date:||February 2014|
|Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
Active Comparator: Arm I: Conventional axillary dissection
Sentinel node resection immediately followed by axillary dissection
Procedure: conventional surgery
Sentinel node resection immediately followed by axillary dissection.
Experimental: Arm II: Sentinel node resection followed by node examination
Sentinel node resection followed by node examination then axillary dissection if positive sentinel node.
Procedure: Sentinel node resection followed by node examination
Sentinel node resection followed by node examination then axillary dissection if positive sentinel node. No axillary dissection for negative sentinel node.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00003830
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|Principal Investigator:||Norman Wolmark, MD||NSABP Foundation Inc|