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
• Interventions: Procedure: Axillary lymph node dissection; Procedure: No axillary lymph node dissection

• 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

Arm && Interventions

Group	Intervention	Description
Axillary Dissection	Axillary lymph node dissection	Patients undergo surgical resection of the primary tumor with axillary lymph node dissection following sentinel lymph node assessment.
No Axillary Dissection	No axillary lymph node dissection	Patients undergo surgical resection of the primary tumor with no axillary lymph node dissection following sentinel lymph node assessment.

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)

European Institute of Oncology; 🇮🇹 Milan, Italy

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

Waikato Hospital; 🇳🇿 Hamilton, New Zealand

Ospedale Alessandro Manzoni; 🇮🇹 Lecco, Italy

Instituto Nacional de Enfermedades Neoplasicas; 🇵🇪 Lima, Peru

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

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

CHU Liege - Domaine Universitaire du Sart Tilman; 🇧🇪 Liege, Belgium

Kantonspital Aarau; 🇨🇭 Aarau, Switzerland

Istituto Scientifico H. San Raffaele; 🇮🇹 Milan, Italy

Institut Gustave Roussy; 🇫🇷 Villejuif, France

Centre Hospitalier Universitaire Vaudois; 🇨🇭 Lausanne, Switzerland

Kantonsspital - St. Gallen; 🇨🇭 St. Gallen, Switzerland

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

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

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

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

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

Horsholm Sygenus; 🇩🇰 Horsholm, Denmark

Hospital de Clinicas de Porto Alegre; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil

North Shore Hospital; 🇳🇿 Auckland, New Zealand

Inselspital Bern; 🇨🇭 Bern, Switzerland

Centro di Riferimento Oncologico - Aviano; 🇮🇹 Aviano, Italy

Ospedali Riuniti di Bergamo; 🇮🇹 Bergamo, Italy

University of Bologna Medical School; 🇮🇹 Bologna, Italy

Universita di Ferrara; 🇮🇹 Ferrara, Italy

Fondazione Salvatore Maugeri; 🇮🇹 Pavia, Italy

Oncology Institute of Southern Switzerland; 🇨🇭 Bellinzona, Switzerland

Royal Melbourne Hospital; 🇦🇺 Parkville, Victoria, Australia

Institute of Oncology - Ljubljana; 🇸🇮 Ljubljana, Slovenia

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