QUADRANTECTOMY PLUS AXILLARY DISSECTION VERSUS QUADRANTECTOMY ALONE IN MAMMOGRAPHIC STAGE T1N0 BREAST CANCER PATIENTS AGED OVER 65 YEARS
- 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
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
- 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
PROJECTED ACCRUAL: A total of 642 patients will be accrued for this study within 3 years.
Allocation: Randomized, Primary Purpose: Treatment
Gabriele Martelli, MD
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
United States: Federal Government