NCT00072293

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 931 (actual)
• Sponsor: ETOP IBCSG Partners Foundation · Network
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	Axillary lymph node dissection	Axillary lymph node dissection
PROCEDURE	No axillary lymph node dissection	Therapeutic conventional surgery

Timeline

• Start date: 2001-12-01
• Primary completion: 2012-09-01
• Completion: 2017-03-31
• First posted: 2003-11-06
• Last updated: 2018-01-23
• Results posted: 2016-05-18

Locations

31 sites across 10 countries: Australia, Belgium, Brazil, Denmark, France, Italy, New Zealand, Peru, Slovenia, Switzerland