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

Last updated on October 11, 2019

FOR MORE INFORMATION
Study Location
Soon Chun Hyang University Hospital Cheonan
Cheonan, Chungcheongnam-do, 330-721 Korea, Republic of
Contact
1-800-718-1021
ClinicalTrials.gov_Inquiries[email protected]
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.

NCT01047358
Pfizer
Completed
Post Marketing Surveillance Study To Observe Safety And Efficacy Of Aromasin In The Patients With Early Or Advanced Breast Cancer

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Descriptive Information
Brief TitlePost Marketing Surveillance Study To Observe Safety And Efficacy Of Aromasin In The Patients With Early Or Advanced Breast Cancer
Official TitlePost Marketing Surveillance Study To Observe Safety And Efficacy Of Aromasin In The Patients With Early Or Advanced Breast Cancer
Brief SummaryThis non-interventional study is to monitor use in real practice in Korea including adverse events on Aromasin (Exemestane).
Detailed DescriptionAll cases at the participating institutions.
Study TypeObservational
Study DesignObservational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-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.
ConditionBreast Cancer
InterventionDrug: 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 StatusCompleted
Actual Enrollment
 (submitted: June 8, 2015)
206
Original Estimated Enrollment
 (submitted: January 8, 2010)
600
Actual Study Completion DateJune 2014
Actual Primary Completion DateJune 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
Ages18 Years and older   (Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesKorea, Republic of
Removed Location Countries  
 
Administrative Information
NCT NumberNCT01047358
Other Study ID NumbersA5991089
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateOctober 2015

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

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Contact

[email protected]

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