Post Marketing Surveillance Study To Observe Safety And Efficacy Of Aromasin In The Patients With Early Or Advanced Breast Cancer

Study Overview
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Brief Summary
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This non-interventional study is to monitor use in real practice in Korea including adverse events on Aromasin (Exemestane).

Detailed Description
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All cases at the participating institutions.

Official Title
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Post Marketing Surveillance Study To Observe Safety And Efficacy Of Aromasin In The Patients With Early Or Advanced Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Aromasin
* Drug: Aromasin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Postmenopausal women with breast cancer eligible for hormonal therapy. Exclusion Criteria: Pregnant breast-feeding premenopausal.

Ages Eligible for Study
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Minimum Age: 18 Years

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 |
| --- | --- |
| ajuvant group<br>adjuvant setting after two to three years of tamoxifen | Drug: Aromasin<br>* 25 mg table QD<br>* Other names: exemestane;|
| palliative group<br>palliative setting after progression of disease with anti-estrogen therapy | Drug: Aromasin<br>* 25 mg table QD<br>* Other names: exemestane;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) | All AEs reported after start of administration of Aromasin were considered as TEAEs and summarized. | From the first dose of Aromasin through the end of the study for an average of 5.6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Without Recurrence/Metastasis (Early Breast Cancer) | The antitumor efficacy for early breast cancer was measured by recurrence/metastasis status (Yes or No) of the participant at the end of the study. The investigator recorded the final evaluation date and the information of tumor recurrence or metastasis (Yes or No) in each participant's case report form (CRF). | At the end of the study, average of 5.6 months. | 
| Time-to-Progression (Early Breast Cancer) | Time-to-Progression was defined as the duration from the date of first administration of Aromasin to the date of recurrence or contralateral breast cancer. | At the end of the study, average of 5.6 months | 
| Percentage of Participants by Overall Tumor Response Assessed Using Response Evaluation Criteria in Solid Tumors (RECIST) (Advanced Breast Cancer) | The antitumor efficacy for advanced breast cancer was measured by objective tumor assessments according to the RECIST of uni-dimensional evaluation. Complete response (CR) was defined as disappearance of all target and non-target lesions, and no new lesions. Partial response (PR) was defined as disappearance of all target lesions, a persistence of ≥1 non-target lesions, no new lesions; or a ≥30% decrease in the sum of the longest dimensions of the target lesions, no unequivocal progression of existing non-target lesions, no new lesions. Stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), no unequivocal progression of existing non-target lesions, and no new lesions. PD was defined as a ≥20% increase in the sum of the longest dimensions of the target lesions; or unequivocal progression of existing non-target lesions, or the appearance of ≥1 new lesions. | At the end of the study, average of 5.6 months |