SOLE, Study of Letrozole Extension, A Phase III Trial Evaluating the Role of Continuous Letrozole Versus Intermittent Letrozole Following 4 to 6 Years of Prior Adjuvant Endocrine Therapy for Postmenopausal Women With Hormone-Receptor Positive, Node Positive Early Stage Breast Cancer
- Compare the disease-free survival (DFS) of postmenopausal women treated with continuous
letrozole for 5 years vs intermittent letrozole over a 5-year period.
- Compare overall survival of patients treated with these two regimens.
- Compare distant DFS of these patients.
- Compare breast cancer-free interval of these patients.
- Compare sites of first DFS failure in these patients.
- Compare second (nonbreast) malignancies in these patients.
- Compare deaths without prior cancer events in these patients.
- Compare adverse events resulting from these two regimens.
OUTLINE: This is a multicenter study. Patients are stratified according to treatment center
and type of prior endocrine therapy (selective estrogen receptor modulators [SERMs] alone vs
aromatase inhibitors [AIs] alone vs both SERMs and AIs each for at least 1 month). Patients
are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral letrozole daily for 5 years.
- Arm II: Patients receive oral letrozole daily for the first 9 months of years 1 through
4, followed by 12 months in year 5.
After completion of study therapy, patients are followed annually.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Disease-free survival (DFS)
estimated 10 years after first patient in
Marco Colleoni, MD
European Institute of Oncology
|Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Faulkner Hospital||Jamaica Plain, Massachusetts 02130|