ER/PR(+), Her2(-) Breast Cancer Clinical Trial
Official title:
The Treatment For Recurrent Female Breast Cancer After Initial Endocrine Therapy Among Taiwanese Population
| NCT number | NCT02924584 |
| Other study ID # | A5481066 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | February 1, 2017 |
| Est. completion date | April 30, 2018 |
| Verified date | June 2018 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 1 |
| Est. completion date | April 30, 2018 |
| Est. primary completion date | February 28, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - hormonal receptor positive, human epidermal growth factor receptor 2 negative breast cancer Exclusion Criteria: |
| Country | Name | City | State |
|---|---|---|---|
| Taiwan | National Cheng Kung University | Tainan City |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
Taiwan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | clinical use of aromatase inhibitors in breast cancer | duration of treatment | base line, up to 60 months | |
| Secondary | prevalence | The prevalence of metastatic breast cancer with positive hormonal receptors with routine practice in Taiwan. | base line up to 60 months | |
| Secondary | dose exposure | The dosage pattern of breast cancer with positive hormonal receptors with routine practice in Taiwan. | base line, up to 60 months | |
| Secondary | overall survival | The overall survival of metastatic breast cancer with positive hormonal receptors with routine practice in Taiwan. | base line, up to 60 months | |
| Secondary | treatment cost | The treatment cost of metastatic breast cancer with positive hormonal receptors with routine practice in Taiwan. | base line, up to 60 months |