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

Study Overview
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Brief Summary
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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
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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 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. Disease Free Survival rate(DFS)-12 months, 24 months 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

Official Title
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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

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Letrozole


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Letrozole, DFS<br>Efficacy evaluation of extended letrozole after 5 year fareston use | Drug: Letrozole<br>* Letrozole 2.5mg<br>* Other names: Femara;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease free survival rate |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast cancer, extended adjuvant hormonal therapy, letrozole, Toremifene