Surgical Resection With or Without Axillary Lymph Node Dissection in Treating Women With Node-Negative Breast Cancer and Sentinel Lymph Node Micrometastases (23-01)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
International Breast Cancer Study Group Identifier:
First received: November 4, 2003
Last updated: August 11, 2015
Last verified: August 2015

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.

Condition Intervention Phase
Breast Cancer
Procedure: axillary lymph node dissection
Procedure: No axillary lymph node dissection
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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

Resource links provided by NLM:

Further study details as provided by International Breast Cancer Study Group:

Primary Outcome Measures:
  • Disease-free survival [ Time Frame: January 2013 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: January 2013 ] [ Designated as safety issue: No ]
  • Systemic disease-free survival [ Time Frame: January 2013 ] [ Designated as safety issue: No ]
  • Incidence of reappearance of disease in the undissected axilla [ Time Frame: January 2013 ] [ Designated as safety issue: No ]
  • Sites of first failure [ Time Frame: January 2013 ] [ Designated as safety issue: No ]
  • Correlation of pathological features with outcome [ Time Frame: January 2013 ] [ Designated as safety issue: No ]
  • Short and long term surgical complications [ Time Frame: January 2013 ] [ Designated as safety issue: No ]

Estimated Enrollment: 1960
Study Start Date: December 2001
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Axillary Dissection Procedure: axillary lymph node dissection
Axillary lymph node dissection
No Axillary Dissection Procedure: No axillary lymph node dissection
Therapeutic conventional surgery

Detailed Description:



  • 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.
  • 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.
  • Correlate pathological features of disease with outcome 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 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.

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


Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • 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



  • Any age


  • Female

Menopausal status

  • Any status

Performance status

  • Not specified

Life expectancy

  • Not specified


  • Not specified


  • See Disease Characteristics


  • Not specified


  • 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


Biologic therapy

  • Not specified


  • Not specified

Endocrine therapy

  • Not specified


  • Not specified


  • See Disease Characteristics


  • No prior systemic therapy for breast cancer
  • More than 1 year since prior chemopreventive agent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00072293

  Hide Study Locations
Australia, New South Wales
Lismore Base Hospital
Lismore, New South Wales, Australia, 2480
St Vincents Hospital
Lismore, New South Wales, Australia, 2480
Mater Hospital - North Sydney
North Sydney, New South Wales, Australia, 2060
Royal North Shore Hospital
St. Leonards, New South Wales, Australia, 2065
Sydney Cancer Centre at Royal Prince Alfred Hospital
Sydney, New South Wales, Australia, 2050
Riverina Cancer Care Centre
Wagga Wagga, New South Wales, Australia, 2650
Westmead Institute for Cancer Research at Westmead Hospital
Westmead, New South Wales, Australia, 2145
Australia, South Australia
Royal Adelaide Hospital Cancer Centre
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Royal Melbourne Hospital
Parkville, Victoria, Australia, 3050
Australia, Western Australia
St. John of God Hospital - Bunbury
Bunbury, Western Australia, Australia, 6230
CHU Liege - Domaine Universitaire du Sart Tilman
Liege, Belgium, B-4000
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90035-003
Horsholm Sygenus
Horsholm, Denmark, 2970
Institut Gustave Roussy
Villejuif, France, F-94805
Centro di Riferimento Oncologico - Aviano
Aviano, Italy, 33081
Ospedali Riuniti di Bergamo
Bergamo, Italy, 24100
University of Bologna Medical School
Bologna, Italy, 40138
Universita di Ferrara
Ferrara, Italy, 44100
Ospedale Alessandro Manzoni
Lecco, Italy, 23900
Istituto Scientifico H. San Raffaele
Milan, Italy, 20132
European Institute of Oncology
Milan, Italy, 20141
Fondazione Salvatore Maugeri
Pavia, Italy, I-27100
New Zealand
North Shore Hospital
Auckland, New Zealand
Waikato Hospital
Hamilton, New Zealand, 2020
Instituto Nacional de Enfermedades Neoplasicas
Lima, Peru, 34
Institute of Oncology - Ljubljana
Ljubljana, Slovenia, Sl-1000
Kantonspital Aarau
Aarau, Switzerland, CH-5001
Oncology Institute of Southern Switzerland
Bellinzona, Switzerland, CH-6500
Inselspital Bern
Bern, Switzerland, CH-3010
Centre Hospitalier Universitaire Vaudois
Lausanne, Switzerland, CH-1011
Kantonsspital - St. Gallen
St. Gallen, Switzerland, CH-9007
Sponsors and Collaborators
International Breast Cancer Study Group
Study Chair: Viviana E. Galimberti European Institute of Oncology
Study Chair: Umberto Veronesi, MD, Prof. European Institute of Oncology
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: International Breast Cancer Study Group Identifier: NCT00072293     History of Changes
Other Study ID Numbers: CDR0000339581  IBCSG 23-01 
Study First Received: November 4, 2003
Last Updated: August 11, 2015
Health Authority: United States: Federal Government

Keywords provided by International Breast Cancer Study Group:
stage IA breast cancer
stage IB breast cancer
stage II breast cancer
estrogen receptor-negative breast cancer
estrogen receptor-positive breast cancer
progesterone receptor-negative breast cancer
progesterone receptor-positive breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasm Micrometastasis
Breast Diseases
Neoplasm Metastasis
Neoplasms by Site
Neoplastic Processes
Pathologic Processes
Skin Diseases processed this record on May 04, 2016