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Trial record 1 of 1 for:    NCT02924584
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Clinical Outcome Of Hormonal Receptor Positive, Her-2 Negative Breast Cancer In Taiwan

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ClinicalTrials.gov Identifier: NCT02924584
Recruitment Status : Completed
First Posted : October 5, 2016
Last Update Posted : June 14, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date October 3, 2016
First Posted Date October 5, 2016
Last Update Posted Date June 14, 2018
Actual Study Start Date February 1, 2017
Actual Primary Completion Date February 28, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 3, 2016)
clinical use of aromatase inhibitors in breast cancer [ Time Frame: base line, up to 60 months ]
duration of treatment
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02924584 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: October 3, 2016)
  • prevalence [ Time Frame: base line up to 60 months ]
    The prevalence of metastatic breast cancer with positive hormonal receptors with routine practice in Taiwan.
  • dose exposure [ Time Frame: base line, up to 60 months ]
    The dosage pattern of breast cancer with positive hormonal receptors with routine practice in Taiwan.
  • overall survival [ Time Frame: base line, up to 60 months ]
    The overall survival of metastatic breast cancer with positive hormonal receptors with routine practice in Taiwan.
  • treatment cost [ Time Frame: base line, up to 60 months ]
    The treatment cost of metastatic breast cancer with positive hormonal receptors with routine practice in Taiwan.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Clinical Outcome Of Hormonal Receptor Positive, Her-2 Negative Breast Cancer In Taiwan
Official Title The Treatment For Recurrent Female Breast Cancer After Initial Endocrine Therapy Among Taiwanese Population
Brief Summary Breast cancer is the most common cancer in Taiwanese women. Most of them were diagnosed in relatively early stages. Only 700 metastatic breast cancer were registered in Official Cancer Registration 2012, while more than11,305 were registered as early breast cancer. With broadly application of aromatase inhibitors, hormonal-receptor-positive breast cancer patients can survive longer and longer. However, there is no prevalence of metastatic breast cancer can be available yet. NHIA database coverage is more than 90% population in Taiwan, thus it can be an appropriate surrogate of prevalence. In this retrospective database analysis, we will explore the real world experience on aromatase inhibitor use for breast cancer in Taiwan.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population hormonal receptor positive, human epidermal growth factor receptor 2 negative breast cancer
Condition ER/PR(+), Her2(-) Breast Cancer
Intervention Not Provided
Study Groups/Cohorts Not Provided
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: October 3, 2016)
1
Original Estimated Enrollment Same as current
Actual Study Completion Date April 30, 2018
Actual Primary Completion Date February 28, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • hormonal receptor positive, human epidermal growth factor receptor 2 negative breast cancer

Exclusion Criteria:

-

Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number NCT02924584
Other Study ID Numbers A5481066
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date June 2018