Tw HER2 Positive Breast Cancer Productivity & Utility Study
NCT ID: NCT04011085
Last Updated: 2019-07-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
300 participants
OBSERVATIONAL
2018-12-24
2019-12-31
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Group1
Patients currently undergoing treatment for early breast cancer (either targeted HER2 therapy and chemotherapy OR targeted HER therapy alone)
No interventions assigned to this group
Group2
Patients with early breast cancer who have completed treatment and are in disease-free survival (i.e. no longer receiving locoregional treatment, chemotherapy or targeted HER2 therapy; patients may still be receiving hormone therapy)
No interventions assigned to this group
Group3
Patients receiving treatment for metastatic breast cancer
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* Unwilling or unable to provide written, informed consent
* Unable to complete written quality of life questionnaires
18 Years
FEMALE
No
Sponsors
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Taiwan Epidemiology Association
OTHER
Responsible Party
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Principal Investigators
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Ching-Hung Lin, Ph.D
Role: STUDY_CHAIR
National Taiwan University Hospital
Liang-Chih Liu, Ph.D
Role: STUDY_CHAIR
China Medical University Hospital
Ming-Feng Hou, M.D.
Role: STUDY_CHAIR
Kaohsiung Medical University
Locations
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National Taiwan University hospital
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Ching-Hung Lin, Ph.D
Role: primary
Other Identifiers
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ML40952
Identifier Type: -
Identifier Source: org_study_id
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