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Completed

NCT Number: NCT00072293

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Lismore Base Hospital, Lismore, New South Wales, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Axillary Lymph Node Dissection

Procedure

Axillary lymph node dissection

No axillary lymph node dissection

Procedure

Therapeutic conventional surgery

Primary outcomes

  1. 5-year Disease-Free Survival

    Time frame: 5-year estimate reported after a median follow-up of 60 months

    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.

Secondary outcomes

  1. 5-year Overall Survival

    Time frame: 5-year estimate reported after a median follow-up of 60 months

    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.

  2. Site of Recurrence

    Time frame: Reported after a median follow-up of 60 months

    Site of recurrence of breast cancer

Sponsors and collaborators

Lead sponsor

ETOP IBCSG Partners Foundation

Network

Registry information

Official study 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

Acronym: 23-01

Important dates

Study start
2001
Primary completion
2012
Study completion
2017
First posted
Nov 6, 2003
Registry last updated
Jan 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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