ER/PR(+), Her2(-) Breast CancerNCT02924584
Clinical Outcome Of Hormonal Receptor Positive, Her-2 Negative Breast Cancer In Taiwan
An observational study of ER/PR(+), Her2(-) Breast Cancer, run by Pfizer at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- ER/PR(+), Her2(-) Breast Cancer
- How many people
- 1 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Feb 2017to 30 Apr 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: hormonal receptor positive, human epidermal growth factor receptor 2 negative breast cancer
Who may be able to join
- hormonal receptor positive, human epidermal growth factor receptor 2 negative breast cancer
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- ER/PR(+), Her2(-) Breast Cancer
- Keywords
- hormonal receptor positive, human epidermal growth factor receptor 2 negative, breast cancer, aromatse inhibitor, overall survival, prevalence
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical use of aromatase inhibitors in breast cancer
duration of treatment
Measured: base line, up to 60 months
Secondary outcomes (4)
prevalence
The prevalence of metastatic breast cancer with positive hormonal receptors with routine practice in Taiwan.
Measured: base line up to 60 months
dose exposure
The dosage pattern of breast cancer with positive hormonal receptors with routine practice in Taiwan.
Measured: base line, up to 60 months
overall survival
The overall survival of metastatic breast cancer with positive hormonal receptors with routine practice in Taiwan.
Measured: base line, up to 60 months
treatment cost
The treatment cost of metastatic breast cancer with positive hormonal receptors with routine practice in Taiwan.
Measured: base line, up to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2016 (estimated)
- Study start1 Feb 2017
- Primary completion28 Feb 2017
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ER/PR(+), Her2(-) Breast CancerStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02924584
- Sponsor's protocol ID
- A5481066
- Other IDs
- NCT02924584
- Status last verified
- Jun 2025
- First submitted
- 3 Oct 2016
- Last updated
- 26 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE TREATMENT FOR RECURRENT FEMALE BREAST CANCER AFTER INITIAL ENDOCRINE THERAPY AMONG TAIWANESE POPULATION
- ClinicalTrials.gov ID
- NCT02924584
- Acronym / sponsor ID
- A5481066
- Conditions
- ER/PR(+), Her2(-) Breast Cancer
- Keywords
- hormonal receptor positive, human epidermal growth factor receptor 2 negative, breast cancer, aromatse inhibitor, overall survival, prevalence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 28 Feb 2017 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 5 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- hormonal receptor positive, human epidermal growth factor receptor 2 negative breast cancer
Key inclusion criteria (1 listed)
- hormonal receptor positive, human epidermal growth factor receptor 2 negative breast cancer
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
clinical use of aromatase inhibitors in breast cancer
Time frame: base line, up to 60 months
duration of treatment
4 secondary outcomes
prevalence
Time frame: base line up to 60 months
dose exposure
Time frame: base line, up to 60 months
overall survival
Time frame: base line, up to 60 months
treatment cost
Time frame: base line, up to 60 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2025.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ER/PR(+), Her2(-) Breast Cancer, run by Pfizer at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical use of aromatase inhibitors in breast cancer (time frame: base line, up to 60 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2025.