NCT00003855

Lymph Node Removal in Treating Women Who Have Stage I or Stage IIA Breast Cancer

A Randomized Trial of Axillary Node Dissection in Women With Clinical T1-2 N0-1 M0 Breast Cancer Who Have a Positive Sentinel Node

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 605 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	axillary lymph node dissection
RADIATION	whole breast irradiation

Timeline

• Start date: 1999-04-01
• Primary completion: 2007-08-01
• Completion: 2011-02-01
• First posted: 2003-01-27
• Last updated: 2020-04-29

Locations

156 sites across 4 countries: United States, Australia, Canada, Ireland