Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-26 @ 4:06 AM
Study NCT ID:
NCT01072318
Status:
UNKNOWN
Last Update Posted:
2010-02-22
First Post:
2010-02-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Extended Adjuvant Treatment With Letrozole in Breast Cancer Who Complete 5 Years of Toremifene
Sponsor:
Korean Breast Cancer Study Group
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2010-02
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LEXTOP
Brief 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
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
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: