Surgical Resection With or Without Axillary Lymph Node Dissection in Treating Women With Node-Negative Breast Cancer and Sentinel Lymph Node Micrometastases

Study Overview
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Brief Summary
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RATIONALE: Surgery to remove lymph nodes in the armpit in patients with sentinel lymph node micrometastases may remove cancer cells that have spread from tumors in the breast. It is not yet known whether surgery to remove the primary tumor is more effective with or without axillary lymph node dissection. PURPOSE: This randomized phase III trial is studying surgery and axillary lymph node dissection to see how well they work compared to surgery alone in treating women with node-negative breast cancer and sentinel lymph node micrometastases.

Detailed Description
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OBJECTIVES: Compare disease-free survival of women with clinically node-negative breast cancer with sentinel lymph node micrometastases treated with surgical resection with or without axillary dissection. Compare overall survival of patients treated with these regimens. Assess sites of recurrence, particularly reappearance of disease in the undissected axilla. Assess long-term surgical complications in patients treated with these regimens. OUTLINE: This is a multicenter study. Patients are stratified according to participating center, menopausal status (pre- vs postmenopausal), and preoperative sentinel node biopsy (yes vs no). Patients are followed every 4 months for 1 year, every 6 months for 4 years, and then annually thereafter.

Official Title
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A Randomized Trial Of Axillary Dissection Versus No Axillary Dissection For Patients With Clinically Node Negative Breast Cancer And Micrometastases In The Sentinel Node

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: Axillary lymph node dissection
* Procedure: No axillary lymph node dissection


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Clinical, mammographic, ultrasonographic, or pathologic diagnosis of unicentric and unifocal breast carcinoma Largest tumor lesion ≤ 5 cm Palpable or nonpalpable breast lesion Preoperative radioactive occult lesion localization, hook wire, or other method of localization required for nonpalpable lesions Prior (preoperative) or planned (intraoperative) sentinel node biopsy required At least 1 micrometastatic (i.e., no greater than 2 mm) sentinel lymph node with no extracapsular extension No clinical evidence of distant metastases No suspicious manifestation of metastases that cannot be ruled out by x-ray, MRI, or CT scan, including the following: Skeletal pain of unknown cause Elevated alkaline phosphatase Bone scan showing hot spots No palpable axillary lymph node(s) No Paget's disease without invasive cancer Hormone receptor status: Estrogen receptor and progesterone receptor known PATIENT CHARACTERISTICS: Age Any age Sex Female Menopausal status Any status Performance status Not specified Life expectancy Not specified Hematopoietic Not specified Hepatic See Disease Characteristics Renal Not specified Other Not pregnant or nursing No other prior or concurrent malignancy except the following: Adequately treated basal cell or squamous cell skin cancer Adequately treated carcinoma in situ of the cervix Adequately treated in situ melanoma Contralateral or ipsilateral carcinoma in situ of the breast No psychiatric, addictive, or other disorder that may compromise ability to give informed consent Geographically accessible for follow-up PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy Not specified Endocrine therapy Not specified Radiotherapy Not specified Surgery See Disease Characteristics Other No prior systemic therapy for breast cancer More than 1 year since prior chemopreventive agent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Axillary Dissection<br>Patients undergo surgical resection of the primary tumor with axillary lymph node dissection following sentinel lymph node assessment. | Procedure: Axillary lymph node dissection<br>* Axillary lymph node dissection<br>|
| Experimental: No Axillary Dissection<br>Patients undergo surgical resection of the primary tumor with no axillary lymph node dissection following sentinel lymph node assessment. | Procedure: No axillary lymph node dissection<br>* Therapeutic conventional surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 5-year Disease-Free Survival | Estimated percentage of patients alive and disease-free at 5 years from randomization, where disease-free survival is defined as the time from randomization to first evidence of invasive relapse at any site, second primary tumor (contralateral or non-breast) or death. | 5-year estimate reported after a median follow-up of 60 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 5-year Overall Survival | Estimated percentage of patients alive and disease-free at 5 years from randomization, where overall survival is defined as the time from randomization to death of any cause. | 5-year estimate reported after a median follow-up of 60 months | 
| Site of Recurrence | Site of recurrence of breast cancer | Reported after a median follow-up of 60 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IA breast cancer, stage IB breast cancer, stage II breast cancer, estrogen receptor-negative breast cancer, estrogen receptor-positive breast cancer, progesterone receptor-negative breast cancer, progesterone receptor-positive breast cancer