Spots Global Cancer Trial Database for Surgical Resection With or Without Axillary Lymph Node Dissection in Treating Women With Node-Negative Breast Cancer and Sentinel Lymph Node Micrometastases
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Trial Identification
Brief Title: Surgical Resection With or Without Axillary Lymph Node Dissection in Treating Women With Node-Negative Breast Cancer and Sentinel Lymph Node Micrometastases
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 ID: NCT00072293
Conditions
Study Description
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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
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
CHU Liege - Domaine Universitaire du Sart Tilman, Liege, , Belgium
Hospital de Clinicas de Porto Alegre, Porto Alegre, Rio Grande Do Sul, Brazil
Horsholm Sygenus, Horsholm, , Denmark
Institut Gustave Roussy, Villejuif, , France
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
Ospedale Alessandro Manzoni, Lecco, , Italy
Istituto Scientifico H. San Raffaele, Milan, , Italy
European Institute of Oncology, Milan, , Italy
Fondazione Salvatore Maugeri, Pavia, , Italy
North Shore Hospital, Auckland, , New Zealand
Waikato Hospital, Hamilton, , New Zealand
Instituto Nacional de Enfermedades Neoplasicas, Lima, , Peru
Institute of Oncology - Ljubljana, Ljubljana, , Slovenia
Kantonspital Aarau, Aarau, , Switzerland
Oncology Institute of Southern Switzerland, Bellinzona, , Switzerland
Inselspital Bern, Bern, , Switzerland
Centre Hospitalier Universitaire Vaudois, Lausanne, , Switzerland
Kantonsspital - St. Gallen, St. Gallen, , Switzerland
Contact Details
Name: Viviana E. Galimberti
Affiliation: European Institute of Oncology
Role: STUDY_CHAIR
Name: Umberto Veronesi, MD, Prof.
Affiliation: European Institute of Oncology
Role: STUDY_CHAIR
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