NCT00553410

Letrozole in Preventing Cancer in Postmenopausal Women Who Have Received 4-6 Years of Hormone Therapy for Hormone Receptor-Positive, Lymph Node-Positive, Early-Stage Breast Cancer

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 4,884 (actual)
• Sponsor: ETOP IBCSG Partners Foundation · Network
• Sex: Female
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Estrogen can cause the growth of breast cancer cells. Letrozole may fight breast cancer by lowering the amount of estrogen the body makes. It is not yet known which regimen of letrozole is more effective in postmenopausal women who have received hormone therapy for early-stage breast cancer. PURPOSE: This randomized phase III trial is comparing two different regimens of letrozole in preventing cancer in postmenopausal women who have received 4-6 years of hormone therapy for hormone receptor-positive, lymph node-positive, early-stage breast cancer.

Detailed description

OBJECTIVES: Primary * Compare the disease-free survival (DFS) of postmenopausal women treated with continuous letrozole for 5 years vs intermittent letrozole over a 5-year period. Secondary * 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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Letrozole	Film-coated tablet, oral use, 2.5 mg Letrozole daily for 5 years continuously
DRUG	Letrozole	Film-coated tablet, oral use, 2.5 mg daily, 48 months over 5 yrs: 4 x 9 months (9 mo followed by 3 mo treatment-free interval in yrs 1-4, -\> 36 mo) plus 1 x 12 mo in yr 5 -\> 48 months

Timeline

• Start date: 2007-08-01
• Primary completion: 2018-04-01
• Completion: 2019-05-15
• First posted: 2007-11-05
• Last updated: 2020-03-11
• Results posted: 2019-01-29

Locations

164 sites across 20 countries: United States, Australia, Austria, Belgium, Chile, Denmark, France, Germany, Hungary, India, Italy, Japan, New Zealand, Peru, Russia, South Africa, Spain, Sweden, Switzerland, United Kingdom