Clinical trial NCT01047358: Post Marketing Surveillance Study To Observe Safety And Efficacy Of Aromasin In The Patients With Early Or Advanced Breast Cancer
Official title: Post Marketing Surveillance Study To Observe Safety And Efficacy Of Aromasin In The Patients With Early Or Advanced Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-01-12
Enrollment: 206
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: - Postmenopausal women diagnosed as estrogen-receptor positive early breast cancer, who have received two to three years of tamoxifen and are switched to AROMASIN for completion of a total of five consecutive years of adjuvant hormonal therapy OR postmenopausal women with breast cancer that has progressed following anti-estrogen therapy.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Pregnant breast-feeding premenopausal.

Primary outcomes:
measure: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: From the first dose of Aromasin through the end of the study for an average of 5.6 months
Secondary outcomes:
measure: Percentage of Participants Without Recurrence/Metastasis (Early Breast Cancer)
timeFrame: At the end of the study, average of 5.6 months.
measure: Time-to-Progression (Early Breast Cancer)
timeFrame: At the end of the study, average of 5.6 months
measure: Percentage of Participants by Overall Tumor Response Assessed Using Response Evaluation Criteria in Solid Tumors (RECIST) (Advanced Breast Cancer)
timeFrame: At the end of the study, average of 5.6 months
Other outcomes:
Locations:
city: Cheonan
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Cheonan
state: Chungcheongnam-do
city: Anyang
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
state: Gyeonggi-do
city: Bucheon
country: Korea, Republic of
facility: Soon Chun Hyang University Bucheon Hospital
state: Gyeonggi-do
city: Goyang
country: Korea, Republic of
facility: Myongji Hospital, Kwangdong Unversity College of Medicine
state: Gyeonggi-do
city: Iksan -si
country: Korea, Republic of
facility: Wonkwang University School of Medicine and Hospital (WUH)
state: Jeollabuk-do
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Korea
city: Cheonnam
country: Korea, Republic of
facility: Hwasun Hospital, Chonnam National University
state: South Jeolla Province
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital
city: Daegu
country: Korea, Republic of
facility: Yeung Nam University Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Seoul
country: Korea, Republic of
facility: Cheil General Hospital & Women's Healthcare Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital (SNUH)
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System, Yonsei Cancer Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center, University of Ulsan
city: Seoul
country: Korea, Republic of
facility: Korea University Medical Center (KUMC) - Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: SMG-SNU Boramae Medical Center
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hospital
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: