QUADRANTECTOMY PLUS AXILLARY DISSECTION VERSUS QUADRANTECTOMY ALONE IN MAMMOGRAPHIC STAGE T1N0 BREAST CANCER PATIENTS AGED OVER 65 YEARS
OBJECTIVES:
- Compare the efficacy of quadrantectomy with or without axillary lymph node dissection,
followed by tamoxifen in terms of local and distant relapse rates and overall survival
of patients with stage I, invasive breast cancer.
- Determine the relationship between biological variables, such as hormone receptor
status, cell proliferation, and DNA ploidy, and the clinical outcome of the disease in
these patients.
OUTLINE: This is a randomized, multicenter study. Patients are stratified by center.
Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo quadrantectomy with dissection of level I and II axillary lymph
nodes.
- Arm II: Patients undergo quadrantectomy without axillary lymph node dissection.
Patients on both arms receive tamoxifen daily for 5 years.
Patients are followed every 4 months for 2 years, every 6 months for 2 years, and then
annually thereafter.
PROJECTED ACCRUAL: A total of 642 patients will be accrued for this study within 3 years.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Gabriele Martelli, MD
Study Chair
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
United States: Federal Government
CDR0000064573
NCT00002720
December 1995
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