NCT01072318

Extended Adjuvant Treatment With Letrozole in Breast Cancer Who Complete 5 Years of Toremifene

Evaluate Efficacy and Safety of Extended Adjuvant Treatment With Letrozole in Postmenopausal Women With Hormone Receptor Positive Breast Cancer Who Have Completed 5 Years of Toremifene

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 495 (estimated)
• Sponsor: Korean Breast Cancer Study Group · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess Efficacy and Safety of Extended Adjuvant Treatment With Letrozole in Postmenopausal Women With Hormone Receptor Positive Breast Cancer Who Complete 5 Years of Toremifene

Detailed description

1. Primary purpose To evaluate disease free survival rate (DFS) after taking 36 months with Letrozole in postmenopausal women with hormone receptor positive breast cancer who complete 5 years of Toremifene 2. Secondary purpose * To evaluate follows after taking 36 months with Letrozole in postmenopausal women with hormone receptor positive breast cancer who complete 5 years of Toremifene. 1. Disease Free Survival rate(DFS)-12 months, 24 months 2. Distant disease free survival rate(DDFS), Overall Survival(OS) * 12 months, 24 months, 36 months c. safety * Change of lipid profiles * Mortality and morbidity due to Cardiovascular disease * Incidence of Fracture * Change of Bone density * Common toxic effect

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Letrozole	Letrozole 2.5mg

Timeline

• Start date: 2010-01-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2010-02-22
• Last updated: 2010-02-22

Locations

1 site across 1 country: South Korea