National Cancer Institute National Cancer Institute
U.S. National Institutes of Health National Cancer Institute
In English | En español
NCI Home Cancer Topics Clinical Trials Cancer Statistics Research & Funding News About NCI
Clinical Trials (PDQ®)
Patient VersionHealth Professional Version
Last Modified: 9/8/2008     First Published: 10/25/2003  
Page Options
Print This Page  Print This Page
E-Mail This Document  E-Mail This Document
Clinical Trial Questions?
Get Help:

1-800-4-CANCER or

LiveHelp online chat

Quick Links
Help Using the NCI Clinical Trials Search Form

Educational Materials About Clinical Trials

About NCI's Cancer Clinical Trials Registry

Dictionary of Cancer Terms

NCI Drug Dictionary
Phase III Randomized Study of Surgical Resection With or Without Axillary Lymph Node Dissection in Women With Clinically Node-Negative Breast Cancer With Sentinel Node Micrometastases

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Surgical Resection With or Without Axillary Lymph Node Dissection in Treating Women With Node-Negative Breast Cancer and Sentinel Lymph Node Micrometastases

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentActiveAny ageOtherIBCSG-23-01
EU-20319, NCT00072293

Objectives

Primary

  1. 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.

Secondary

  1. Compare overall survival of patients treated with these regimens.
  2. Compare the incidence of reappearance of disease in the undissected axilla, sites of first failure, and short- and long-term surgical complications in patients treated with these regimens.
  3. Correlate pathological features of disease with outcome in patients treated with these regimens.

Entry Criteria

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

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

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

Expected Enrollment

1960

Approximately 1,960 patients will be accrued for this study.

Outcomes

Primary Outcome(s)

Disease-free survival

Secondary Outcome(s)

Overall survival
Systemic disease-free survival
Incidence of reappearance of disease in the undissected axilla
Sites of first failure
Correlation of pathological features with outcome
Short and long term surgical complications

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 randomized to 1 of 2 treatment arms.

  • Arm I: Patients undergo surgical resection of the primary tumor with axillary lymph node dissection.
  • Arm II: Patients undergo surgical resection of the primary tumor without axillary lymph node dissection.

Patients in both arms may receive adjuvant therapy based on biological factors determined on the primary tumor or subsequent disease recurrence.

Patients are followed every 4 months for 1 year, every 6 months for 4 years, and then annually thereafter.

Trial Contact Information

Trial Lead Organizations

International Breast Cancer Study Group

Viviana Galimberti, Protocol chair
Ph: 39-02-5748-9725
Email: viviana.galimberti@ieo.it
Umberto Veronesi, MD, Protocol co-chair
Ph: 39-257-489-224
Email: direzione.scientifica@ieo.it

Trial Sites

Australia
New South Wales
  Lismore
 Lismore Base Hospital
 ANZ BCTG Operations Office - Department of Surgical Oncology
Ph: 61-2-4985-0166
 St Vincents Hospital
 ANZ BCTG Operations Office - Department of Surgical Oncology
Ph: 61-2-4985-0166
  North Sydney
 Mater Hospital - North Sydney
 ANZ BCTG Operations Office - Department of Surgical Oncology
Ph: 61-2-4985-0166
  St. Leonards
 Royal North Shore Hospital
 ANZ BCTG Operations Office - Department of Surgical Oncology
Ph: 61-2-4985-0166
  Sydney
 Sydney Cancer Centre at Royal Prince Alfred Hospital
 ANZ BCTG Operations Office - Department of Surgical Oncology
Ph: 61-2-4985-0166
  Wagga Wagga
 Riverina Cancer Care Centre
 ANZ BCTG Operations Office - Department of Surgical Oncology
Ph: 61-2-4985-0166
  Westmead
 Westmead Institute for Cancer Research at Westmead Hospital
 ANZ BCTG Operations Office - Department of Surgical Oncology
Ph: 61-2-4985-0166
South Australia
  Adelaide
 Royal Adelaide Hospital Cancer Centre
 ANZ BCTG Operations Office - Department of Surgical Oncology
Ph: 61-2-4985-0166
Victoria
  Parkville
 Royal Melbourne Hospital
 ANZ BCTG Operations Office - Department of Surgical Oncology
Ph: 61-2-4985-0166
Western Australia
  Bunbury
 St. John of God Hospital - Bunbury
 ANZ BCTG Operations Office - Department of Surgical Oncology
Ph: 61-2-4985-0166
Belgium
  Liege
 CHU Liege - Domaine Universitaire du Sart Tilman
 Contact Person
Ph: 32-4-366-7111
Brazil
Rio Grande do Sul
  Porto Alegre
 Hospital de Clinicas de Porto Alegre
 Carlos Menke, MD, PhD
Ph: 55-51-9986-9736
 Email: menke@hcpa.ufrgs.br
Denmark
  Horsholm
 Horsholm Sygenus
 Hanne Galatius, MD
Ph: 45-48-296-961
 Email: haga@noh.regionh.dk
France
  Villejuif
 Institut Gustave Roussy
 Contact Person
Ph: 33-1-4211-4339
Italy
  Aviano
 Centro di Riferimento Oncologico - Aviano
 Ezio Candiani, MD
Ph: 39-4-3465-9257
 Email: ecandiani@cro.it
  Bergamo
 Ospedali Riuniti di Bergamo
 Carlo Tondini, MD
Ph: 39-03-526-6424
 Email: carlo.tondoni@ospedaliriuniti.bergamo.it
  Bologna
 University of Bologna Medical School
 Mario Taffurelli, MD
Ph: 39-051-636-3584
  Ferrara
 Universita di Ferrara
 Paolo Carcoforo, MD
Ph: 39-05-3223-6385
 Email: ccf@unife.it
  Lecco
 Ospedale Alessandro Manzoni
 Angelo Recalcati
Ph: 39-3-4148-9312
 Email: a.recalcati@tiscalinet.it
  Milan
 European Institute of Oncology
 Viviana Galimberti
Ph: 39-02-5748-9725
 Email: viviana.galimberti@ieo.it
 Istituto Scientifico H. San Raffaele
 Contact Person
Ph: 39-2-2643-2754
  Pavia
 Fondazione Salvatore Maugeri
 Corrado Tinterri, MD
Ph: 39-03-8259-2272
 Email: ctinterri@fsm.it
New Zealand
  Auckland
 North Shore Hospital
 ANZ BCTG Operations Office - Department of Surgical Oncology
Ph: 61-2-4985-0166
  Hamilton
 Waikato Hospital
 ANZ BCTG Operations Office - Department of Surgical Oncology
Ph: 61-2-4985-0166
Peru
  Lima
 Instituto Nacional de Enfermedades Neoplasicas
 Julio Abugattas
Ph: 51-1-710-6900 ext. 2242
 Email: jabugattas@inen.sld.pe
Slovenia
  Ljubljana
 Institute of Oncology - Ljubljana
 Jurij Lindtner, MD
Ph: 386-1-587-9535
Switzerland
  Aarau
 Kantonspital Aarau
 Dimitri Sarlos
Ph: 41-62-838-5065
 Email: dimtri.sarlos@ksa.ch
  Bellinzona
 Oncology Institute of Southern Switzerland
 Olivia Pagani, MD
Ph: 41-91-811-3395
 Email: olivia.pagani@ibcsg.org
  Bern
 Inselspital Bern
 Stefan Aebi, MD
Ph: 41-31-6321-661
 Email: stefan.aebi@insel.ch
  Lausanne
 Centre Hospitalier Universitaire Vaudois
 Jean-Francois Delaloye, MD
Ph: 41-21-314-0146
 Email: jean-francois.delaloye@chuv.ch
  St. Gallen
 Kantonsspital - St. Gallen
 Monika Bamert, MD
Ph: 41-71-494-1161
 Email: monika.bamert@kssg.ch

Registry Information
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
Trial Start Date 2001-12-11
Registered in ClinicalTrials.gov NCT00072293
Date Submitted to PDQ 2003-09-23
Information Last Verified 2008-09-08

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

Back to TopBack to Top

A Service of the National Cancer Institute
Department of Health and Human Services National Institutes of Health USA.gov