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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
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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Letrozole, DFS | Experimental | Efficacy evaluation of extended letrozole after 5 year fareston use |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Letrozole | Drug | Letrozole 2.5mg |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Disease free survival rate | 3 years |
| 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 |
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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
Estrogen receptor(+) or Progesterone receptor(+)
No Evidence of Recurrence
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sei-Hyun Ahn, MD | Department of Surgery, Asan medical center, South Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Surgery, Asan medical center | Seoul | South Korea |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000077289 | Letrozole |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 |
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| 12, 24, 36 months |
| Toxicity was assessed by NCI-CTC version 3.0 | 36 months |
| D017437 |
| Skin and Connective Tissue Diseases |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |