Suspended

Tw HER2 Positive Breast Cancer Productivity & Utility Study

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being collected

Data Collection

Collected at a single point in time - Cross-sectional
Who is being recruted

Over 18 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: December 2018
See protocol details

Summary

Principal SponsorTaiwan Epidemiology Association
Study ContactChao-Hsiun Tang, Ph.D
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: December 24, 2018

Actual date on which the first participant was enrolled.

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.

Official TitleTw HER2 Positive Breast Cancer Productivity & Utility Study
NCT04011085
Principal SponsorTaiwan Epidemiology Association
Study ContactChao-Hsiun Tang, Ph.D
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

300 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

4 inclusion criteria required to participate
Aged 18 years or over;
Diagnosed with early stage or metastatic (Stage IV) HER2-positive breast cancer (confirmed by the study site physician). [HER2-positive is defined as IHC3+ and/or ISH≥2.0]
eBC patients should have received at least 2 cycles of adjuvant anti-cancer therapy following surgery at time of interview; metastasis breast cancer (mBC) patients should have received at least 1 cycle of treatment for their metastatic disease at time of interview.
Able to provide written, informed consent.
3 exclusion criteria prevent from participating
Patients with ECOG performance status (PS) ≥3
Unwilling or unable to provide written, informed consent
Unable to complete written quality of life questionnaires

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

National Taiwan University hospital

Taipei, TaiwanOpen National Taiwan University hospital in Google Maps
SuspendedOne Study Center
Tw HER2 Positive Breast Cancer Productivity & Utility Study | PatLynk