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

Not Applicable

Completed

• Conditions: Breast Cancer

• Registration Number: NCT00072293
• Lead Sponsor: ETOP IBCSG Partners Foundation

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 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.

Study Timeline

• Study Start: 2001-12
• Study First Submitted: 2003-11-04
• Study First Submitted QC: 2003-11-05
• Study First Posted: 2003-11-06
• Primary Completion: 2012-09
• Results First Submitted: 2016-02-26
• Results First Submitted QC: 2016-04-12
• Results First Posted: 2016-05-18
• Study Completion: 2017-03-31
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-22
• Last Update Posted: 2018-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 931

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
5-year Disease-Free Survival	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.

Secondary Outcome Measures

Name	Time	Method
Site of Recurrence	Reported after a median follow-up of 60 months	Site of recurrence of breast cancer
5-year Overall Survival	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.

Trial Locations

Locations (31)

Lismore Base Hospital; 🇦🇺 Lismore, New South Wales, Australia

St Vincents Hospital; 🇦🇺 Lismore, New South Wales, Australia

Mater Hospital - North Sydney; 🇦🇺 North Sydney, New South Wales, Australia

Royal North Shore Hospital; 🇦🇺 St. Leonards, New South Wales, Australia

Sydney Cancer Centre at Royal Prince Alfred Hospital; 🇦🇺 Sydney, New South Wales, Australia

Riverina Cancer Care Centre; 🇦🇺 Wagga Wagga, New South Wales, Australia

Westmead Institute for Cancer Research at Westmead Hospital; 🇦🇺 Westmead, New South Wales, Australia

Royal Adelaide Hospital Cancer Centre; 🇦🇺 Adelaide, South Australia, Australia

Royal Melbourne Hospital; 🇦🇺 Parkville, Victoria, Australia

St. John of God Hospital - Bunbury; 🇦🇺 Bunbury, Western Australia, Australia

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