Letrozole Adjuvant Therapy Duration (LEAD) Study: Standard Versus Long Treatment. A Phase III Trial in Post-Menopausal Women With Early Breast Cancer.
- To compare the disease-free survival of previously treated, post-menopausal women with
early-stage breast cancer treated with standard- (2-3 years of tamoxifen followed by
2-3 years of letrozole) versus long-treatment (2-3 years of tamoxifen followed by 5
years of letrozole) adjuvant letrozole.
- To compare the overall survival of these patients.
- To compare the safety of these patients.
OUTLINE: Patients are randomized to 1 or 2 treatment arms.
- Arm I (standard treatment): Patients previously treated with tamoxifen for 2 years
receive letrozole for an additional 3 years; patients previously treated with tamoxifen
for 3 years receive letrozole for an additional 2 years; and patients previously
treated with tamoxifen for 2-3 years receive letrozole , so the total duration of the
endocrine treatment (i.e., tamoxifen followed by letrozole) is 5 years.
- Arm II (long treatment): Patients receive letrozole for an additional 5 years
regardless of the duration of the previous tamoxifen treatment.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Lucia Del Mastro, MD
National Institute for Cancer Research, Italy