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| ID | Type | Description | Link |
|---|---|---|---|
| IBCSG 23-01 | Other Identifier | IBCSG |
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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.
OBJECTIVES:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Axillary Dissection | Active Comparator | Patients undergo surgical resection of the primary tumor with axillary lymph node dissection following sentinel lymph node assessment. |
|
| No Axillary Dissection | Experimental | Patients undergo surgical resection of the primary tumor with no axillary lymph node dissection following sentinel lymph node assessment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Axillary lymph node dissection | Procedure | Axillary lymph node dissection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Site of Recurrence |
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DISEASE CHARACTERISTICS:
Clinical, mammographic, ultrasonographic, or pathologic diagnosis of unicentric and unifocal breast carcinoma
Largest tumor lesion ≤ 5 cm
Palpable or nonpalpable breast lesion
Prior (preoperative) or planned (intraoperative) sentinel node biopsy required
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:
No palpable axillary lymph node(s)
No Paget's disease without invasive cancer
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
Not pregnant or nursing
No other prior or concurrent malignancy except the following:
No psychiatric, addictive, or other disorder that may compromise ability to give informed consent
Geographically accessible for follow-up
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Name | Affiliation | Role |
|---|---|---|
| Viviana E. Galimberti | European Institute of Oncology | Study Chair |
| Umberto Veronesi, MD, Prof. | European Institute of Oncology | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lismore Base Hospital | Lismore | New South Wales | 2480 | Australia | ||
| St Vincents Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30196031 | Derived | 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. | |
| 23491275 |
| Label | URL |
|---|---|
| Abstract from paper published in Lancet Oncology, 2013 | View source |
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Accrual began April 1, 2001 and closed February 28, 2010, after 934 patients from 27 centers in Europe, South America and Australia were randomized.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | No Axillary Dissection |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| No axillary lymph node dissection |
| Procedure |
Therapeutic conventional surgery |
|
Site of recurrence of breast cancer |
| Reported after a median follow-up of 60 months |
| Lismore |
| New South Wales |
| 2480 |
| Australia |
| Mater Hospital - North Sydney | North Sydney | New South Wales | 2060 | Australia |
| Royal North Shore Hospital | St Leonards | New South Wales | 2065 | Australia |
| Sydney Cancer Centre at Royal Prince Alfred Hospital | Sydney | New South Wales | 2050 | Australia |
| Riverina Cancer Care Centre | Wagga Wagga | New South Wales | 2650 | Australia |
| Westmead Institute for Cancer Research at Westmead Hospital | Westmead | New South Wales | 2145 | Australia |
| Royal Adelaide Hospital Cancer Centre | Adelaide | South Australia | 5000 | Australia |
| Royal Melbourne Hospital | Parkville | Victoria | 3050 | Australia |
| St. John of God Hospital - Bunbury | Bunbury | Western Australia | 6230 | Australia |
| CHU Liege - Domaine Universitaire du Sart Tilman | Liège | B-4000 | Belgium |
| Hospital de Clinicas de Porto Alegre | Porto Alegre | Rio Grande do Sul | 90035-003 | Brazil |
| Horsholm Sygenus | Hørsholm | 2970 | Denmark |
| Institut Gustave Roussy | Villejuif | F-94805 | France |
| Centro di Riferimento Oncologico - Aviano | Aviano | 33081 | Italy |
| Ospedali Riuniti di Bergamo | Bergamo | 24100 | Italy |
| University of Bologna Medical School | Bologna | 40138 | Italy |
| Universita di Ferrara | Ferrara | 44100 | Italy |
| Ospedale Alessandro Manzoni | Lecco | 23900 | Italy |
| Istituto Scientifico H. San Raffaele | Milan | 20132 | Italy |
| European Institute of Oncology | Milan | 20141 | Italy |
| Fondazione Salvatore Maugeri | Pavia | I-27100 | Italy |
| North Shore Hospital | Auckland | New Zealand |
| Waikato Hospital | Hamilton | 2020 | New Zealand |
| Instituto Nacional de Enfermedades Neoplasicas | Lima | 34 | Peru |
| Institute of Oncology - Ljubljana | Ljubljana | Sl-1000 | Slovenia |
| Kantonspital Aarau | Aarau | CH-5001 | Switzerland |
| Oncology Institute of Southern Switzerland | Bellinzona | CH-6500 | Switzerland |
| Inselspital Bern | Bern | CH-3010 | Switzerland |
| Centre Hospitalier Universitaire Vaudois | Lausanne | CH-1011 | Switzerland |
| Kantonsspital - St. Gallen | Sankt Gallen | CH-9007 | Switzerland |
| Derived |
| 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. |
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 |
| COMPLETED |
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| NOT COMPLETED |
|
|
Intention-to-treat
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Intention-to-treat | Posted | Number | percentage of participants | 5-year estimate reported after a median follow-up of 60 months |
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| 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. | Intention-to-treat | Posted | Number | percentage of participants | 5-year estimate reported after a median follow-up of 60 months |
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| Secondary | Site of Recurrence | Site of recurrence of breast cancer | Intention-to-treat | Posted | Number | participants | Reported after a median follow-up of 60 months |
|
|
5-years. Treating physician assessed and reported long-term surgical events (sensory neuropathy, lymphoedema and motor neuropathy) at every follow-up visit (every 4 months from date of randomization for the first year and every six months from years 2-5).
Analysis population excludes 31 patients (17 in Axillary Dissection group/14 in No Axillary Dissection group) who did not receive the randomly-assigned treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 1 | 447 | 178 | 447 | ||
| EG001 | 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 | 0 | 453 | 83 | 453 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Post-operative infection (L.axilla) | Infections and infestations | CTCAE (2.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Sensory neuropathy | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Lymphedema | Vascular disorders | CTCAE (2.0) | Systematic Assessment |
| |
| Motor neuropathy | Nervous system disorders | CTCAE (2.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rudolf Maibach, Executive Officer for International Trial Activities | IBCSG | +41 31 389 91 96 | rudolf.maibach@ibcsg.org |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Male |
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