Surgical Resection With or Without Axillary Lymph Node Dissection in Treating Women With Node-Negative Breast Cancer and Sentinel Lymph Node Micrometastases
NCT ID: NCT00072293
Last Updated: 2018-01-23
Study Results
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View full resultsBasic Information
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COMPLETED
NA
931 participants
INTERVENTIONAL
2001-12-31
2017-03-31
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Axillary Dissection
Patients undergo surgical resection of the primary tumor with axillary lymph node dissection following sentinel lymph node assessment.
Axillary lymph node dissection
Axillary lymph node dissection
No Axillary Dissection
Patients undergo surgical resection of the primary tumor with no axillary lymph node dissection following sentinel lymph node assessment.
No axillary lymph node dissection
Therapeutic conventional surgery
Interventions
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Axillary lymph node dissection
Axillary lymph node dissection
No axillary lymph node dissection
Therapeutic conventional surgery
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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ETOP IBCSG Partners Foundation
NETWORK
Responsible Party
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Principal Investigators
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Viviana E. Galimberti
Role: STUDY_CHAIR
European Institute of Oncology
Umberto Veronesi, MD, Prof.
Role: STUDY_CHAIR
European Institute of Oncology
Locations
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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
Liège, , Belgium
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Horsholm Sygenus
Hørsholm, , 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
Sankt Gallen, , Switzerland
Countries
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References
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Galimberti V, Cole BF, Viale G, Veronesi P, Vicini E, Intra M, Mazzarol G, Massarut S, Zgajnar J, Taffurelli M, Littlejohn D, Knauer M, Tondini C, Di Leo A, Colleoni M, Regan MM, Coates AS, Gelber RD, Goldhirsch A; International Breast Cancer Study Group Trial 23-01. Axillary dissection versus no axillary dissection in patients with breast cancer and sentinel-node micrometastases (IBCSG 23-01): 10-year follow-up of a randomised, controlled phase 3 trial. Lancet Oncol. 2018 Oct;19(10):1385-1393. doi: 10.1016/S1470-2045(18)30380-2. Epub 2018 Sep 5.
Galimberti V, Cole BF, Zurrida S, Viale G, Luini A, Veronesi P, Baratella P, Chifu C, Sargenti M, Intra M, Gentilini O, Mastropasqua MG, Mazzarol G, Massarut S, Garbay JR, Zgajnar J, Galatius H, Recalcati A, Littlejohn D, Bamert M, Colleoni M, Price KN, Regan MM, Goldhirsch A, Coates AS, Gelber RD, Veronesi U; International Breast Cancer Study Group Trial 23-01 investigators. Axillary dissection versus no axillary dissection in patients with sentinel-node micrometastases (IBCSG 23-01): a phase 3 randomised controlled trial. Lancet Oncol. 2013 Apr;14(4):297-305. doi: 10.1016/S1470-2045(13)70035-4. Epub 2013 Mar 11.
Related Links
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Abstract from paper published in Lancet Oncology, 2013
Other Identifiers
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IBCSG 23-01
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000339581
Identifier Type: -
Identifier Source: org_study_id
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