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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.
Sponsor:
Information provided by (Responsible Party):
International Breast Cancer Study Group
ClinicalTrials.gov Identifier:
NCT00072293
First received: November 4, 2003
Last updated: April 12, 2016
Last verified: April 2016

November 4, 2003
April 12, 2016
December 2001
November 2011   (final data collection date for primary outcome measure)
5-year Disease-Free Survival [ Time Frame: 5-year estimate reported after a median follow-up of 60 months ] [ Designated as safety issue: No ]
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.
Not Provided
Complete list of historical versions of study NCT00072293 on ClinicalTrials.gov Archive Site
  • 5-year Overall Survival [ Time Frame: 5-year estimate reported after a median follow-up of 60 months ] [ Designated as safety issue: No ]
    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.
  • Site of Recurrence [ Time Frame: Reported after a median follow-up of 60 months ] [ Designated as safety issue: No ]
    Site of recurrence of breast cancer
Not Provided
Not Provided
Not Provided
 
Surgical Resection With or Without Axillary Lymph Node Dissection in Treating Women With Node-Negative Breast Cancer and Sentinel Lymph Node Micrometastases
A Randomized Trial Of Axillary Dissection Versus No Axillary Dissection For Patients With Clinically Node Negative Breast Cancer And Micrometastases In The Sentinel Node

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:

  • 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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • Procedure: Axillary lymph node dissection
    Axillary lymph node dissection
  • Procedure: No axillary lymph node dissection
    Therapeutic conventional surgery
  • Active Comparator: Axillary Dissection
    Patients undergo surgical resection of the primary tumor with axillary lymph node dissection following sentinel lymph node assessment.
    Intervention: Procedure: Axillary lymph node dissection
  • Experimental: No Axillary Dissection
    Patients undergo surgical resection of the primary tumor with no axillary lymph node dissection following sentinel lymph node assessment.
    Intervention: Procedure: No axillary lymph node dissection
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. Erratum in: Lancet Oncol. 2013 Jun;14(7):e254.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
934
December 2021
November 2011   (final data collection date for primary outcome measure)

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
Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Belgium,   Brazil,   Denmark,   France,   Italy,   New Zealand,   Peru,   Slovenia,   Switzerland
 
NCT00072293
CDR0000339581, IBCSG 23-01
Yes
Not Provided
Not Provided
International Breast Cancer Study Group
International Breast Cancer Study Group
Not Provided
Study Chair: Viviana E. Galimberti European Institute of Oncology
Study Chair: Umberto Veronesi, MD, Prof. European Institute of Oncology
International Breast Cancer Study Group
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP