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

Overview

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 2014

Detailed Description

All cases at the participating institutions.

Interventions

  • Drug: Aromasin
    • 25 mg table QD
  • Drug: Aromasin
    • 25 mg table QD

Arms, Groups and Cohorts

  • ajuvant group
    • adjuvant setting after two to three years of tamoxifen
  • palliative group
    • palliative setting after progression of disease with anti-estrogen therapy

Clinical Trial Outcome Measures

Primary Measures

  • Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
    • Time Frame: From the first dose of Aromasin through the end of the study for an average of 5.6 months
    • All AEs reported after start of administration of Aromasin were considered as TEAEs and summarized.

Secondary Measures

  • Percentage of Participants Without Recurrence/Metastasis (Early Breast Cancer)
    • Time Frame: At the end of the study, average of 5.6 months.
    • The antitumor efficacy for early breast cancer was measured by recurrence/metastasis status (Yes or No) of the participant at the end of the study. The investigator recorded the final evaluation date and the information of tumor recurrence or metastasis (Yes or No) in each participant’s case report form (CRF).
  • Time-to-Progression (Early Breast Cancer)
    • Time Frame: At the end of the study, average of 5.6 months
    • Time-to-Progression was defined as the duration from the date of first administration of Aromasin to the date of recurrence or contralateral breast cancer.
  • Percentage of Participants by Overall Tumor Response Assessed Using Response Evaluation Criteria in Solid Tumors (RECIST) (Advanced Breast Cancer)
    • Time Frame: At the end of the study, average of 5.6 months
    • The antitumor efficacy for advanced breast cancer was measured by objective tumor assessments according to the RECIST of uni-dimensional evaluation. Complete response (CR) was defined as disappearance of all target and non-target lesions, and no new lesions. Partial response (PR) was defined as disappearance of all target lesions, a persistence of ≥1 non-target lesions, no new lesions; or a ≥30% decrease in the sum of the longest dimensions of the target lesions, no unequivocal progression of existing non-target lesions, no new lesions. Stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), no unequivocal progression of existing non-target lesions, and no new lesions. PD was defined as a ≥20% increase in the sum of the longest dimensions of the target lesions; or unequivocal progression of existing non-target lesions, or the appearance of ≥1 new lesions.

Participating in This Clinical Trial

Inclusion Criteria

  • – Postmenopausal women with breast cancer eligible for hormonal therapy. Exclusion Criteria:

  • Pregnant breast-feeding premenopausal.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Pfizer
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Pfizer CT.gov Call Center, Study Director, Pfizer

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