- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02924584
Clinical Outcome Of Hormonal Receptor Positive, Her-2 Negative Breast Cancer In Taiwan
June 23, 2025 updated by: Pfizer
THE TREATMENT FOR RECURRENT FEMALE BREAST CANCER AFTER INITIAL ENDOCRINE THERAPY AMONG TAIWANESE POPULATION
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Tainan City, Taiwan
- National Cheng Kung University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
hormonal receptor positive, human epidermal growth factor receptor 2 negative breast cancer
Description
Inclusion Criteria:
- hormonal receptor positive, human epidermal growth factor receptor 2 negative breast cancer
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
clinical use of aromatase inhibitors in breast cancer
Time Frame: base line, up to 60 months
|
duration of treatment
|
base line, up to 60 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
prevalence
Time Frame: base line up to 60 months
|
The prevalence of metastatic breast cancer with positive hormonal receptors with routine practice in Taiwan.
|
base line up to 60 months
|
|
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.
|
base line, up to 60 months
|
|
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.
|
base line, up to 60 months
|
|
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.
|
base line, up to 60 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2017
Primary Completion (Actual)
February 28, 2017
Study Completion (Actual)
April 30, 2018
Study Registration Dates
First Submitted
October 3, 2016
First Submitted That Met QC Criteria
October 3, 2016
First Posted (Estimated)
October 5, 2016
Study Record Updates
Last Update Posted (Actual)
June 26, 2025
Last Update Submitted That Met QC Criteria
June 23, 2025
Last Verified
June 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- A5481066
- NCT02924584 (Registry Identifier: ClinicalTrials.gov)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g.
protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions.
Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.