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

NCT01047358

Last updated date
Study Location
Soon Chun Hyang University Hospital Cheonan
Cheonan, Chungcheongnam-do, 330-721, Korea, Republic of
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Cancer
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Pregnant breast-feeding premenopausal.

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ALL GENDERS
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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
  • ajuvant group
    adjuvant setting after two to three years of tamoxifen
    Intervention: Drug: Aromasin
  • palliative group
    palliative setting after progression of disease with anti-estrogen therapy
    Intervention: Drug: Aromasin
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
 (submitted: June 8, 2015)
206
Original Estimated Enrollment
 (submitted: January 8, 2010)
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:

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

Exclusion Criteria:

  • Pregnant breast-feeding premenopausal.
Sex/Gender
Sexes Eligible for Study:Female
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
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date October 2015