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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

Brief 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 Summary:

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.


Sponsor: International Breast Cancer Study Group

Current Primary Outcome: 5-year Disease-Free Survival [ Time Frame: 5-year estimate reported after a median follow-up of 60 months ]

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.


Original Primary Outcome:

Current Secondary Outcome:

  • 5-year Overall Survival [ Time Frame: 5-year estimate reported after a median follow-up of 60 months ]
    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.
  • Site of Recurrence [ Time Frame: Reported after a median follow-up of 60 months ]
    Site of recurrence of breast cancer


Original Secondary Outcome:

Information By: International Breast Cancer Study Group

Dates:
Date Received: November 4, 2003
Date Started: December 2001
Date Completion: December 2021
Last Updated: April 12, 2016
Last Verified: April 2016