Clinical Outcomes After Letrozole Treatment According to the Estrogen Receptor Expression in Postmenopausal Women

Study Overview
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Brief Summary
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The purpose of this study is to assess clinical outcomes after Letrozole treatment according to the estrogen receptor expression in postmenopausal women with hormone receptor positive breast cancer.

Detailed Description
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This study aimed at evaluating following: Validity Assessment: Primary End Point: To evaluate 5-year diseae free survival rate after Letrozole treatment according to the estrogen receptor expression in postmenopausal women Secondary End Point: To evaluate overall survival rate(OS) and Time to distance recurrence(TTDR) after Hormonal therapy in postmenopausal women with hormone receptor positive breast cancer Safety Assessment: To evaluate all adverse events including serious adverse events after Letrozole treatment.

Official Title
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Assessment of Clinical Outcomes After Letrozole Treatment According to the Estrogen Receptor Expression in Postmenopausal Women With Hormone Receptor Positive Breast Cancer

Conditions
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Breast Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with estrogen receptor(+) and/or progesterone receptor(+) Postmenopausal state was defined the following conditions, at least one of a, b Serum FSH ≥ 30 mIU/mL and Amenorrhea ≥ 1 year for below 55 years, over than 55 years Bilateral oophorectomy Patients have undergone surgery of the breast cancer within 12 weeks and terminated chemotherapy after surgery within 4 weeks. WHO(ECOG) performance status 0-2 Adequate haematological function, renal function, hepatic function. No evidence of metastasis. Exclusion Criteria: Metachronous bilateral breast cancer. Metastatic breast cancer (stage IV) Other hormone therapy and Hormonal replacement therapy given within the previous 4 weeks, except for Estring, Vagifem, Estrogen Cream. Patients with Child-Pugh grade C, serum creatinine>2xUNL Patients with gastrectomy, small bowel resection, malabsorption syndrome and dysphagia.
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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ER expression : Low<br>Patients were postmenopausal women with hormone receptor positive breast cancer. All patients should be 3 or 4 point of total Allred score. | |
| ER expression : Intermediate<br>Patients were postmenopausal women with hormone receptor positive breast cancer. All patients should be 5 or 6 point of total Allred score. | |
| ER expression : High<br>Patients were postmenopausal women with hormone receptor positive breast cancer. All patients should be 7 or 8 point of total Allred score. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease free survival |  | the first 5 years after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse effect |  | the first 5 years after enrollment | 
| Overall Survival |  | the first 5 years after enrollment | 
| Time to Distant Recurrence (TTDR) |  | the first 5 years after enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast cancer, Letrozole, postmenopause, hormone receptor positive breast cancer