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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01047358
• Other study ID #: A5991089
• Status: Completed
• Phase: N/A
• First received: December 24, 2009
• Last updated: October 6, 2015
• Start date: June 2010
• Est. completion date: June 2014

Study information

• Verified date: October 2015
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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

Description:

All cases at the participating institutions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• - Postmenopausal women with breast cancer eligible for hormonal therapy.

Exclusion Criteria:

• Pregnant breast-feeding premenopausal.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Aromasin
25 mg table QD
• Aromasin
25 mg table QD

Locations

Country	Name	City	State
Korea, Republic of	Hallym University Sacred Heart Hospital	Anyang	Gyeonggi-do
Korea, Republic of	Soon Chun Hyang University Bucheon Hospital	Bucheon	Gyeonggi-do
Korea, Republic of	Inje University Busan Paik Hospital	Busan
Korea, Republic of	Soon Chun Hyang University Hospital Cheonan	Cheonan	Chungcheongnam-do
Korea, Republic of	Hwasun Hospital, Chonnam National University	Cheonnam	South Jeolla Province
Korea, Republic of	Yeung Nam University Hospital	Daegu
Korea, Republic of	Myongji Hospital, Kwangdong Unversity College of Medicine	Goyang	Gyeonggi-do
Korea, Republic of	Seoul National University Bundang Hospital	Gyeonggi-do
Korea, Republic of	Wonkwang University School of Medicine and Hospital (WUH)	Iksan -si	Jeollabuk-do
Korea, Republic of	Inha University Hospital	Incheon
Korea, Republic of	Asan Medical Center	Seoul	Korea
Korea, Republic of	Asan Medical Center, University of Ulsan	Seoul
Korea, Republic of	Cheil General Hospital & Women's Healthcare Center	Seoul
Korea, Republic of	Ewha Womans University Mokdong Hospital	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Korea University Medical Center (KUMC) - Korea University Guro Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul National University Hospital	Seoul
Korea, Republic of	Seoul National University Hospital (SNUH)	Seoul
Korea, Republic of	Severance Hospital, Yonsei University Health System, Yonsei Cancer Center	Seoul
Korea, Republic of	SMG-SNU Boramae Medical Center	Seoul
Korea, Republic of	Ajou University Hospital	Suwon

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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.	No
Secondary	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	No
Secondary	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	No

External Links

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