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.
OBJECTIVES: * 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.
Sentinel node resection immediately followed by axillary dissection.
Sentinel node resection followed by node examination then axillary dissection if positive sentinel node. No axillary dissection for negative sentinel node.
Morbidity - Number of Participants With Residual Shoulder Abduction Deficit
Morbidity as measured by residual shoulder abduction deficit. Shoulder Abduction Deficit definition: Shoulder range of motion decreased by greater than or equal to 10% as compared with that measured prior to surgery.
Time frame: Before and after surgery (within 30 days of randomization)
Morbidity - Number of Participants With Residual Arm Volume Difference
Morbidity as measured by residual arm volume difference. Residual Arm Volume Difference definition: Arm volume differences greater than or equal to 10% as compared with that measured prior to surgery
Time frame: before and after surgery (within 30 days of randomization)
Morbidity - Number of Participants With Residual Arm Numbness
Morbidity as measured by residual arm numbness
Time frame: before and after surgery (within 30 days of randomization)
Morbidity - Number of Participants With Residual Arm Tingling
Morbidity as measured by residual arm tingling
Time frame: before and after surgery (within 30 days of randomization)
Overall Survival
Measured at the time from randomization to any death to determine the percentage of patients alive at 8 years
Time frame: 8 years
Disease-free Survival as Measured by Breast Cancer Recurrence, Any Second Primary Cancer, and Death From Any Cause in Patients Without a Prior Event.
Measured at time from randomization to recurrence, second primary, or death to determine the percentage of patients disease free at 8 years.
Time frame: 8 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
5,611
MBCCOP - Gulf Coast
Mobile, Alabama, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
Loma Linda University Cancer Institute at Loma Linda University Medical Center
Loma Linda, California, United States
Sutter Breast Cancer Group
Sacramento, California, United States
Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego
San Diego, California, United States
Stanford Cancer Center at Stanford University Medical Center
Stanford, California, United States
Hartford Hospital
Hartford, Connecticut, United States
MBCCOP - Howard University Cancer Center
Washington D.C., District of Columbia, United States
Halifax Medical Center
Daytona Beach, Florida, United States
...and 68 more locations
Pathology Investigation of Sentinel Nodes in Sentinel Node Negative Patients to Identify a Group Who Were Potentially at Increased Risk of Systemic Recurrence
Percentage of patients distant disease-free at 5 years. Sentinel node definition: Sentinel nodes are the first few lymph nodes into which a tumor drains. Sentinel node biopsy requires injecting a tracer material to help a surgeon locate sentinel nodes during surgery.
Time frame: From the time of randomization until 5 years
Pathology Investigation of Sentinel Nodes in Sentinel Node Negative Patients to Identify a Group Who Were Potentially at Increased Risk of Systemic Recurrence
Measured at time from randomization to any distant cancer or death to determine percentage of patients distant disease free at 5 years. Sentinel node definition: Sentinel nodes are the first few lymph nodes into which a tumor drains. Sentinel node biopsy requires injecting a tracer material to help a surgeon locate sentinel nodes during surgery.
Time frame: From the time of randomization until 5 years
The Percentage of Technically Successful Sentinel Node Resections as Measured by the Proportion of Patients for Whom at Least One Sentinel Node is Identified.
Sentinel node definition: Sentinel nodes are the first few lymph nodes into which a tumor drains. Sentinel node biopsy requires injecting a tracer material to help a surgeon locate sentinel nodes during surgery.
Time frame: At time of surgery (within 30 days of randomization)
Sensitivity of the Sentinel Node to Determine Presence of Nodal Metastases.
Sentinel node definition: Sentinel nodes are the first few lymph nodes into which a tumor drains. Sentinel node biopsy requires injecting a tracer material to help a surgeon locate sentinel nodes during surgery.
Time frame: At time of surgery (within 30 days of randomization)