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

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ClinicalTrials.gov Identifier: NCT01047358
Recruitment Status : Completed
First Posted : January 12, 2010
Results First Posted : June 9, 2015
Last Update Posted : October 8, 2015
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date December 24, 2009
First Posted Date January 12, 2010
Results First Submitted Date May 26, 2015
Results First Posted Date June 9, 2015
Last Update Posted Date October 8, 2015
Study Start Date June 2010
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 26, 2015)
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.
Original Primary Outcome Measures
 (submitted: January 8, 2010)
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 ]
Change History
Current Secondary Outcome Measures
 (submitted: May 26, 2015)
  • 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.
Original Secondary Outcome Measures
 (submitted: January 8, 2010)
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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Center Pfizer
PRS Account Pfizer
Verification Date October 2015