This non-interventional study is to monitor use in real practice in Korea including adverse events on Aromasin (Exemestane).
All cases at the participating institutions.
Study Type
OBSERVATIONAL
Enrollment
206
Soon Chun Hyang University Hospital Cheonan
Cheonan, Chungcheongnam-do, South Korea
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
All AEs reported after start of administration of Aromasin were considered as TEAEs and summarized.
Time frame: From the first dose of Aromasin through the end of the study for an average of 5.6 months
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).
Time frame: 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.
Time frame: 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.
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Hallym University Sacred Heart Hospital
Anyang-si, Gyeonggi-do, South Korea
Soon Chun Hyang University Bucheon Hospital
Bucheon-si, Gyeonggi-do, South Korea
Myongji Hospital, Kwangdong Unversity College of Medicine
Goyang-si, Gyeonggi-do, South Korea
Wonkwang University School of Medicine and Hospital (WUH)
Iksan -si, Jeollabuk-do, South Korea
Asan Medical Center
Seoul, Korea, South Korea
Seoul National University Hospital (SNUH)
Seoul, Seoul, South Korea
Hwasun Hospital, Chonnam National University
Cheonnam, South Jeolla Province, South Korea
Inje University Busan Paik Hospital
Busan, South Korea
Yeung Nam University Hospital
Daegu, South Korea
...and 12 more locations
Time frame: At the end of the study, average of 5.6 months