Breast Cancer Clinical Trial
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
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.
OBJECTIVES:
Primary objectives:
Long term: To assess whether overall survival for patients randomized to Arm 2 (no immediate
ALND) is essentially equivalent to (or better than) than that for patients assigned to Arm 1
(completion ALND).
Short term: To quantify and compare the surgical morbidities associated with SLND plus ALND
versus SLND alone.
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.
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