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: August 19, 2014
Last verified: August 2014
  Purpose

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:

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

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  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 ClinicalTrials.gov identifier: NCT00072293

  Show 31 Study Locations
Sponsors and Collaborators
International Breast Cancer Study Group
Investigators
Study Chair: Viviana E. Galimberti European Institute of Oncology
Study Chair: Umberto Veronesi, MD, Prof. European Institute of Oncology
  More Information

Additional Information:
No publications provided by International Breast Cancer Study Group

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: International Breast Cancer Study Group
ClinicalTrials.gov Identifier: NCT00072293     History of Changes
Other Study ID Numbers: CDR0000339581, IBCSG 23-01
Study First Received: November 4, 2003
Last Updated: August 19, 2014
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
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on September 15, 2014