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

Completed

Conditions: Breast Cancer

Interventions: Drug: Aromasin

Registration Number: NCT01047358

Lead Sponsor: Pfizer

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

Detailed Description: All cases at the participating institutions.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 206

Inclusion Criteria

- Postmenopausal women with breast cancer eligible for hormonal therapy.

Exclusion Criteria

Pregnant breast-feeding premenopausal.

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ajuvant group	Aromasin	adjuvant setting after two to three years of tamoxifen
palliative group	Aromasin	palliative setting after progression of disease with anti-estrogen therapy

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants by Overall Tumor Response Assessed Using Response Evaluation Criteria in Solid Tumors (RECIST) (Advanced Breast Cancer)	At the end of the study, average of 5.6 months	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.
Percentage of Participants Without Recurrence/Metastasis (Early Breast Cancer)	At the end of the study, average of 5.6 months.	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-to-Progression (Early Breast Cancer)	At the end of the study, average of 5.6 months	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.

Trial Locations

Locations (22): Soon Chun Hyang University Hospital Cheonan
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Cheonan, Chungcheongnam-do, Korea, Republic of
Hallym University Sacred Heart Hospital
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Anyang, Gyeonggi-do, Korea, Republic of
Soon Chun Hyang University Bucheon Hospital
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Bucheon, Gyeonggi-do, Korea, Republic of
Myongji Hospital, Kwangdong Unversity College of Medicine
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Goyang, Gyeonggi-do, Korea, Republic of
Wonkwang University School of Medicine and Hospital (WUH)
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Iksan -si, Jeollabuk-do, Korea, Republic of
Asan Medical Center
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Seoul, Korea, Korea, Republic of
Hwasun Hospital, Chonnam National University
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Cheonnam, South Jeolla Province, Korea, Republic of
Inje University Busan Paik Hospital
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Busan, Korea, Republic of
Yeung Nam University Hospital
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Daegu, Korea, Republic of
Seoul National University Bundang Hospital
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Gyeonggi-do, Korea, Republic of
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Soon Chun Hyang University Hospital Cheonan
🇰🇷Cheonan, Chungcheongnam-do, Korea, Republic of