Post Marketing Surveillance Study To Observe Safety And Efficacy Of Aromasin In The Patients With Early Or Advanced Breast Cancer
NCT01047358
Last updated date
ABOUT THIS STUDY
This non-interventional study is to monitor use in real practice in Korea including adverse
events on Aromasin (Exemestane).
Study Location
Soon Chun Hyang University Hospital Cheonan
Cheonan, Chungcheongnam-do, 330-721, Korea, Republic of
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
Breast Cancer
Sex
Female
Age
18 + years
Inclusion Criteria
Show details
- - Postmenopausal women with breast cancer eligible for hormonal therapy.
Exclusion Criteria
Show details
- Pregnant breast-feeding premenopausal.
NEED INFO?
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ALL GENDERS
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years
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Advanced Information
Descriptive Information | ||||
---|---|---|---|---|
Brief Title | 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 | |||
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. | |||
Study Type | Observational | |||
Study Design | Observational Model: Case-Only Time Perspective: Prospective | |||
Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
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. | |||
Condition | Breast Cancer | |||
Intervention | Drug: Aromasin
25 mg table QD Other Name: exemestane | |||
Study Groups/Cohorts |
| |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment | 206 | |||
Original Estimated Enrollment | 600 | |||
Actual Study Completion Date | June 2014 | |||
Actual Primary Completion Date | June 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender |
| |||
Ages | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Korea, Republic of | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT01047358 | |||
Other Study ID Numbers | A5991089 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor | Pfizer | |||
Collaborators | Not Provided | |||
Investigators |
| |||
PRS Account | Pfizer | |||
Verification Date | October 2015 |