Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments axillary lymph node dissection, no axillary lymph node dissection
Phase phase 3
Sponsor International Breast Cancer Study Group
Start date December 2001
End date September 2012
Trial size 1960 participants
Trial identifier NCT00072293, CDR0000339581, IBCSG 23-01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Arm
(Other)
axillary lymph node dissection
Axillary lymph node dissection
(Other)
no axillary lymph node dissection
Therapeutic conventional surgery

Primary Outcomes

Measure
Disease-free survival
time frame: January 2013

Secondary Outcomes

Measure
Overall survival
time frame: January 2013
Systemic disease-free survival
time frame: January 2013
Incidence of reappearance of disease in the undissected axilla
time frame: January 2013
Sites of first failure
time frame: January 2013
Correlation of pathological features with outcome
time frame: January 2013
Short and long term surgical complications
time frame: January 2013

Eligibility Criteria

Female participants of any age.

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

Additional Information

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
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by International Breast Cancer Study Group.