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Clinical Trials (PDQ®)

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
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentClosedAny ageOtherCDR0000339581
IBCSG 23-01, EU-20319, NCT00072293

Trial Description

Summary

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.

Further Study Information

OBJECTIVES:

Primary

  • 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

  • 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.

Eligibility 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

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

Trial Contact Information

Trial Lead Organizations/Sponsors

International Breast Cancer Study Group

Viviana Enrica GalimbertiStudy Chair

Umberto Veronesi, MD, Prof.Study Chair

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00072293
ClinicalTrials.gov processed this data on November 12, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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