Extended Adjuvant Treatment With Letrozole in Breast Cancer Who Complete 5 Years of Toremifene
NCT ID: NCT01072318
Last Updated: 2010-02-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
495 participants
INTERVENTIONAL
2010-01-31
2014-01-31
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Letrozole, DFS
Efficacy evaluation of extended letrozole after 5 year fareston use
Letrozole
Letrozole 2.5mg
Interventions
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Letrozole
Letrozole 2.5mg
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Removed the breast cancer histologically or cytologically
3. No evidence of breast cancer in controlateral breast
4. No evidence of metastasis
5. Postmenopausal Women With Hormone Receptor Positive Breast Cancer Who Complete 5 Years of Toremifene in 30 months
6. Postmenopausal state was defined the following conditions, at least one of a, b
1. Serum FSH ≥ 30 mIU/mL
2. Amenorrhea ≥ 1 year
7. Estrogen receptor(+) or Progesterone receptor(+)
8. No Evidence of Recurrence
Exclusion Criteria
2. Patients with malignancies
3. Patients with other aromatase inhibitor and chemotherapy
4. Patients with Other hormone therapy and Hormonal replacement therapy
5. Patients with Hormone replacement therapy during taking Toremifene
6. Estimated life expectancy of \<12 months
7. WBC\<3,000/mm3 or Platelet count\<100,000/mm3
8. AST and/or ALT ≥2xUNL
9. Alkaline phosphatase ≥2xUNL
FEMALE
No
Sponsors
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Korean Breast Cancer Study Group
OTHER
Responsible Party
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Asan medical center
Principal Investigators
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Sei-Hyun Ahn, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Surgery, Asan medical center, South Korea
Locations
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Department of Surgery, Asan medical center
Seoul, , South Korea
Countries
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Other Identifiers
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KBCSG007
Identifier Type: -
Identifier Source: org_study_id
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