Lymph Node Removal in Treating Women Who Have Stage I or Stage IIA Breast Cancer
Recruitment status was Active, not recruiting
RATIONALE: Surgery to remove lymph nodes in the armpit may remove cancer cells that have spread from tumors in the breast.
PURPOSE: Randomized phase III trial to determine the effectiveness of removing lymph nodes in the armpit in treating women who have stage I or stage IIA breast cancer.
Procedure: axillary lymph node dissection
Radiation: whole breast irradiation
|Study Design:||Allocation: Randomized
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized Trial of Axillary Node Dissection in Women With Clinical T1-2 N0-1 M0 Breast Cancer Who Have a Positive Sentinel Node|
|Study Start Date:||April 1999|
- Determine whether axillary lymph node dissection (ALND) improves overall survival in women with stage I or IIA breast cancer.
- Quantify and compare surgical morbidities associated with sentinel lymph node dissection with or without ALND in these patients.
OUTLINE: This is a randomized study. After segmental mastectomy and sentinel lymph node dissection, patients are stratified according to age (50 and under vs over 50), estrogen receptor status (positive vs negative), and tumor size (no greater than 1 cm vs greater than 1 cm but no greater than 2 cm vs greater than 2 cm). Patients are randomized to one of two treatment arms.
- Arm I: Patients undergo axillary lymph node dissection involving removal of at least level I and II nodes, followed by whole-breast radiotherapy (exclusive of a third supraclavicular field) 5 days a week for a maximum of 7 weeks.
- Arm II: Patients undergo breast radiotherapy only as in arm I. Patients in both arms may receive adjuvant systemic therapy at the discretion of the treating physician.
Patients are followed up at 30 days, at 6, 12, 18, 30, and 36 months, and then annually for a total of 10 years.
PROJECTED ACCRUAL: Approximately 1,900 patients (950 per treatment arm) will be accrued for this study within 3.8 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003855
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|Study Chair:||Armando E. Giuliano, MD||John Wayne Cancer Institute at Saint John's Health Center|