Clinical Trials Directory

Trials / Unknown

UnknownNCT04011085

Tw HER2 Positive Breast Cancer Productivity & Utility Study

Status
Unknown
Phase
Study type
Observational
Enrollment
300 (estimated)
Sponsor
Taiwan Epidemiology Association · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

Summary

Breast cancer ranks top 4 Taiwan mortality cause in 2016 and the incidence rate has been increasing. Since advances in screening and treatment over last decades, disease-free survival in HER2 positive breast cancer improved and relapse rates decrease as well. While health-related quality of life (HRQoL) and productivity benefit is not currently formally assessed by Taiwan Health Technology Agency (HTA) in Taiwan, the value of therapy in terms of a wider societal benefit is a critical factor which is increasingly being considered as part of the overall assessment of the value of a new medicine. Sort of productivity study in cancer is lack of in Taiwan. Referenced Roche UK team published comprehensive productivity studies1 Taiwan Epidemiology Association wants to initiate study to understand holistic value in each stage of breast cancer and quantify the value of new drug to support HTA assessment. The data will be collected through study, and adapt to cost-effectiveness model for future reimbursement submission.

Detailed description

Breast cancer ranks top 4 Taiwan mortality cause in 2016 and the incidence rate has been increasing. Since advances in screening and treatment over last decades, disease-free survival in HER2 positive breast cancer improved and relapse rates decrease as well. While health-related quality of life (HRQoL) and productivity benefit is not currently formally assessed by Taiwan Health Technology Agency (HTA) in Taiwan, the value of therapy in terms of a wider societal benefit is a critical factor which is increasingly being considered as part of the overall assessment of the value of a new medicine. Sort of productivity study in cancer is lack of in Taiwan. Referenced Roche UK team published comprehensive productivity studies1 Taiwan Epidemiology Association wants to initiate study to understand holistic value in each stage of breast cancer and quantify the value of new drug to support HTA assessment. The data will be collected through study, and adapt to cost-effectiveness model for future reimbursement submission.

Conditions

Timeline

Start date
2018-12-24
Primary completion
2019-12-31
Completion
2019-12-31
First posted
2019-07-08
Last updated
2019-07-08

Locations

1 site across 1 country: Taiwan

Source: ClinicalTrials.gov record NCT04011085. Inclusion in this directory is not an endorsement.