Extended Adjuvant Treatment With Letrozole in Breast Cancer Who Complete 5 Years of Toremifene
LEXTOP
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
1 other identifier
interventional
495
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 breast-cancer
Started Jan 2010
Typical duration for phase_4 breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 14, 2010
CompletedFirst Posted
Study publicly available on registry
February 22, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedFebruary 22, 2010
February 1, 2010
4 years
February 14, 2010
February 18, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Disease free survival rate
3 years
Secondary Outcomes (4)
Disease free survival rate
12 months, 24 months
Distant disease free survival rate
12 months, 24 months, 36 months
Overall survival rate
12, 24, 36 months
Toxicity was assessed by NCI-CTC version 3.0
36 months
Study Arms (1)
Letrozole, DFS
EXPERIMENTALEfficacy evaluation of extended letrozole after 5 year fareston use
Interventions
Eligibility Criteria
You may qualify if:
- Patients have undergone surgery of the breast cancer and proven histologically to be invasive breast cancer.
- Removed the breast cancer histologically or cytologically
- No evidence of breast cancer in controlateral breast
- No evidence of metastasis
- Postmenopausal Women With Hormone Receptor Positive Breast Cancer Who Complete 5 Years of Toremifene in 30 months
- Postmenopausal state was defined the following conditions, at least one of a, b
- Serum FSH ≥ 30 mIU/mL
- Amenorrhea ≥ 1 year
- Estrogen receptor(+) or Progesterone receptor(+)
- No Evidence of Recurrence
You may not qualify if:
- Patient with hormone receptor negative
- Patients with malignancies
- Patients with other aromatase inhibitor and chemotherapy
- Patients with Other hormone therapy and Hormonal replacement therapy
- Patients with Hormone replacement therapy during taking Toremifene
- Estimated life expectancy of \<12 months
- WBC\<3,000/mm3 or Platelet count\<100,000/mm3
- AST and/or ALT ≥2xUNL
- Alkaline phosphatase ≥2xUNL
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Surgery, Asan medical center
Seoul, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sei-Hyun Ahn, MD
Department of Surgery, Asan medical center, South Korea
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 14, 2010
First Posted
February 22, 2010
Study Start
January 1, 2010
Primary Completion
January 1, 2014
Study Completion
January 1, 2014
Last Updated
February 22, 2010
Record last verified: 2010-02