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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- Compare the long term control of regional disease by sentinel node resection vs sentinel node resection followed by conventional axillary dissection in women with breast cancer who are clinically node negative and pathologically sentinel node negative.
- Compare the effect of these two regimens on the overall and disease-free survival of these patients.
- Compare the morbidity associated with these two regimens in these patients.
- Compare the prognostic value of these two regimens in patients who are sentinel node negative or positive by pathology.
- Determine whether a more detailed pathology investigation can identify a group of patients with a potentially increased risk of systemic recurrence who are node negative by pathology.
- Determine the technical success rate of sentinel node dissection and the variability of technical success rate in a broad population of surgeons.
- Determine the sensitivity of the sentinel node to determine the presence of nodal metastases in these patients.
Objectives of quality of life questionnaire in sentinel node-negative patients:
- Compare the severity of self-assessed symptoms and activity limitations of patients treated with these two regimens.
- Compare the severity of self-assessed symptoms and activity limitations after breast cancer surgery in patients whose surgery was on the dominant side vs patients whose surgery was on the non-dominant side.
- Compare the impact of arm edema, range of motion, and sensory neuropathy on self-assessed measures of daily functioning, symptoms, and overall quality of life of patients treated with these regimens.
OUTLINE: This is a randomized study. Patients are stratified according to the surgical treatment plan (lumpectomy vs mastectomy), age (49 and under vs 50 and over), and clinical tumor size (no greater than 2.0 cm vs 2.1-4.0 cm vs at least 4.1 cm). Patients are randomized to one of two surgery arms.
All patients receive technetium (Tc 99m) sulfur colloid injected into normal breast tissue within 1 cm of the primary tumor or biopsy cavity and an intradermal injection of technetium (Tc 99m) sulfur colloid, approximately 0.5-8 hours before surgery. Patients also receive an injection of isosulfan blue dye around the tumor or biopsy cavity after a hot spot is identified with a gamma detector. If a hot spot is not identified, the blue dye is injected after a saline bolus injection.
- Arm I: Patients undergo sentinel node resection immediately followed by conventional axillary dissection.
- Arm II: Patients undergo sentinel node resection and an intraoperative examination of sentinel nodes.
Patients with positive sentinel nodes undergo axillary dissection after sentinel node resection.
Patients with cytologically negative sentinel nodes do not undergo axillary dissection.
Patients with cytologically negative but histologically positive sentinel nodes return to surgery for axillary dissection.
Patients with histologically positive sentinel nodes and those in whom the sentinel node is not identified undergo axillary dissection after sentinel node resection.
Patients with pathologically positive, nonaxillary sentinel nodes undergo axillary dissection after sentinel node resection.
Patients with evidence of tumor remaining after surgery undergo a total mastectomy.
Quality of life is assessed at baseline, at weeks 1-3, and then every 6 months for 3 years or until recurrence.
Patients are followed at 1 and 3 weeks, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: Approximately 5,400 patients will be accrued for this study within 4 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003830
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|Principal Investigator:||Norman Wolmark, MD||NSABP Foundation Inc|