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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01047358
First received: December 24, 2009
Last updated: May 6, 2013
Last verified: May 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Breast Cancer
 Drug: Aromasin
 Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Post Marketing Surveillance Study To Observe Safety And Efficacy Of Aromasin In The Patients With Early Or Advanced Breast Cancer

Resource links provided by NLM:

Drug Information available for: Exemestane
U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • The nature, incidence, duration, and severity of adverse events; discontinuation due to adverse events; outcome and causality will be monitored in this study. [ Time Frame: adjuvant 1 year ; advanced 6 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Efficacy assessments based on objective tumor assessments according to the Response Evaluation Criteria in Solid Tumors(RECIST) of uni-dimensional evaluation. [ Time Frame: adjuvant 1 year ; advanced 6 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: August 2010
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
ajuvant group
adjuvant setting after two to three years of tamoxifen
 Drug: Aromasin
25 mg table QD
Other Name: exemestane
palliative group
palliative setting after progression of disease with anti-estrogen therapy
 Drug: Aromasin
25 mg table QD
Other Name: exemestane

Detailed Description:

All cases at the participating institutions.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

  • Postmenopausal women with breast cancer eligible for hormonal therapy.

Exclusion Criteria:

  • Pregnant breast-feeding premenopausal.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01047358

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01047358     History of Changes
Other Study ID Numbers: A5991089
Study First Received: December 24, 2009
Last Updated: May 6, 2013
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Exemestane
 Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 21, 2013