Breast Cancer Clinical Trial
— 23-01Official 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
Verified date | December 2017 |
Source | International Breast Cancer Study Group |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 931 |
Est. completion date | March 31, 2017 |
Est. primary completion date | September 2012 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
DISEASE CHARACTERISTICS: - Clinical, mammographic, ultrasonographic, or pathologic diagnosis of unicentric and unifocal breast carcinoma - Largest tumor lesion = 5 cm - Palpable or nonpalpable breast lesion - Preoperative radioactive occult lesion localization, hook wire, or other method of localization required for nonpalpable lesions - Prior (preoperative) or planned (intraoperative) sentinel node biopsy required - At least 1 micrometastatic (i.e., no greater than 2 mm) sentinel lymph node with no extracapsular extension - No clinical evidence of distant metastases - No suspicious manifestation of metastases that cannot be ruled out by x-ray, MRI, or CT scan, including the following: - Skeletal pain of unknown cause - Elevated alkaline phosphatase - Bone scan showing hot spots - No palpable axillary lymph node(s) - No Paget's disease without invasive cancer - Hormone receptor status: - Estrogen receptor and progesterone receptor known PATIENT CHARACTERISTICS: Age - Any age Sex - Female Menopausal status - Any status Performance status - Not specified Life expectancy - Not specified Hematopoietic - Not specified Hepatic - See Disease Characteristics Renal - Not specified Other - Not pregnant or nursing - No other prior or concurrent malignancy except the following: - Adequately treated basal cell or squamous cell skin cancer - Adequately treated carcinoma in situ of the cervix - Adequately treated in situ melanoma - Contralateral or ipsilateral carcinoma in situ of the breast - No psychiatric, addictive, or other disorder that may compromise ability to give informed consent - Geographically accessible for follow-up PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Not specified Endocrine therapy - Not specified Radiotherapy - Not specified Surgery - See Disease Characteristics Other - No prior systemic therapy for breast cancer - More than 1 year since prior chemopreventive agent |
Country | Name | City | State |
---|---|---|---|
Australia | Royal Adelaide Hospital Cancer Centre | Adelaide | South Australia |
Australia | St. John of God Hospital - Bunbury | Bunbury | Western Australia |
Australia | 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 Melbourne Hospital | Parkville | Victoria |
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 |
Belgium | CHU Liege - Domaine Universitaire du Sart Tilman | Liege | |
Brazil | Hospital de Clinicas de Porto Alegre | Porto Alegre | Rio Grande Do Sul |
Denmark | Horsholm Sygenus | Horsholm | |
France | Institut Gustave Roussy | Villejuif | |
Italy | 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 | European Institute of Oncology | Milan | |
Italy | Istituto Scientifico H. San Raffaele | Milan | |
Italy | Fondazione Salvatore Maugeri | Pavia | |
New Zealand | North Shore Hospital | Auckland | |
New Zealand | Waikato Hospital | Hamilton | |
Peru | Instituto Nacional de Enfermedades Neoplasicas | Lima | |
Slovenia | Institute of Oncology - Ljubljana | Ljubljana | |
Switzerland | 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 |
Lead Sponsor | Collaborator |
---|---|
International Breast Cancer Study Group |
Australia, Belgium, Brazil, Denmark, France, Italy, New Zealand, Peru, Slovenia, Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 5-year Disease-Free Survival | 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 estimate reported after a median follow-up of 60 months | |
Secondary | 5-year Overall Survival | 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. | 5-year estimate reported after a median follow-up of 60 months | |
Secondary | Site of Recurrence | Site of recurrence of breast cancer | Reported after a median follow-up of 60 months |
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