Surgical Resection With or Without Axillary Lymph Node Dissection in Treating Women With Node-Negative Breast Cancer and Sentinel Lymph Node Micrometastases (23-01)
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|ClinicalTrials.gov Identifier: NCT00072293|
Recruitment Status : Completed
First Posted : November 6, 2003
Results First Posted : May 18, 2016
Last Update Posted : January 23, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Procedure: Axillary lymph node dissection Procedure: No axillary lymph node dissection||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||931 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||December 2001|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||March 31, 2017|
Active Comparator: Axillary Dissection
Patients undergo surgical resection of the primary tumor with axillary lymph node dissection following sentinel lymph node assessment.
Procedure: Axillary lymph node dissection
Axillary lymph node dissection
Experimental: No Axillary Dissection
Patients undergo surgical resection of the primary tumor with no axillary lymph node dissection following sentinel lymph node assessment.
Procedure: No axillary lymph node dissection
Therapeutic conventional surgery
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00072293
|Study Chair:||Viviana E. Galimberti||European Institute of Oncology|
|Study Chair:||Umberto Veronesi, MD, Prof.||European Institute of Oncology|