This disease registry is a prospective, multicenter non-interventional study designed to observe anti-cancer treatment regimens and clinical outcomes in participants with HER2-positive unresectable locally advanced breast cancer (LABC) or metastatic breast cancer (MBC).
Study Type
OBSERVATIONAL
Enrollment
110
Bank of Cyprus Oncology Center
Nicosia, Cyprus
Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine
Athens, Greece
Anticancer Hospital Ag. Savas ; 2Nd Dept. of Oncology - Internal Medicine
Athens, Greece
Percentage of Participants Receiving Each Unique Treatment Regimen Overall
Time frame: Baseline up to approximately 8 years
Percentage of Participants Receiving Each Unique Treatment Regimen as First-Line Versus Subsequent-Line Therapy
Time frame: Baseline up to approximately 8 years
Percentage of Participants Receiving Each Unique Treatment Regimen Sequence
Time frame: Baseline up to approximately 8 years
Progression-Free Survival (PFS)
Tumor response will be evaluated by the Investigator according to site-/country-specific medical practice. Study protocol does not specify any particular method of assessment.
Time frame: From start date of anti-cancer treatment regimen to the date of either disease progression or death (up to approximately 8 years)
Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
Time frame: Baseline up to approximately 8 years
Percentage of Participants Receiving Each Treatment Regimen, by Participant Characteristics
Time frame: Baseline up to approximately 8 years
Percentage of Participants Receiving Each Treatment Regimen, by Country/Region
Time frame: Baseline up to approximately 8 years
Overall Survival (OS)
Time frame: From the date of initiation of treatment to the date of death from any cause (up to approximately 8 years)
Number of Treatment Regimens Received
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ARETAIEION UNIVERSITY HOSPITAL; oncology unit
Athens, Greece
251 Air Force General Hospital-Oncology Clinic
Athens, Greece
Agioi Anargyroi; 3Rd Dept. of Medical Oncology
Athens, Greece
IASO
Athens, Greece
IASO General Hospital of Athens
Athens, Greece
Attikon University Hospital; 4th Department of Internal Medicine
Haidari, Greece
Metropolitan Hospital; 2Nd Oncology Clinic
Piraeus, Greece
...and 2 more locations
Time frame: Baseline up to approximately 8 years
Percentage of Participants With Complete Response (CR) or Partial Response (PR) - Objective Response Rate (ORR)
Tumor response will be evaluated by the Investigator according to site-/country-specific medical practice. Study protocol does not specify any particular method of assessment.
Time frame: From the date of initiation of treatment to the date of disease progression or death from any cause (up to approximately 8 years)
Duration of Response (DOR)
Tumor response will be evaluated by the Investigator according to site-/country-specific medical practice. Study protocol does not specify any particular method of assessment.
Time frame: From date of first response (CR or PR) to the date of disease progression (up to approximately 8 years)
Percentage of Participants by Reasons for Treatment Modification
Time frame: Baseline up to approximately 8 years
EuroQoL 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Score
Time frame: Baseline up to approximately 8 years
Functional Assessment of Cancer Therapy-Breast (FACT-B) Questionnaire Score
Time frame: Baseline up to approximately 8 years
Work Productivity and Activity Impairment-General Health (WPAI-GH) Questionnaire Score
Time frame: Baseline up to approximately 8 years
Percentage of Participants With HER2 Retesting
Time frame: Baseline up to approximately 8 years
Percentage of Participants With HER2 Overexpression, as Assessed Using In Situ Hybridization or Immunohistochemistry
Time frame: Baseline up to approximately 8 years
Healthcare Resource Utilization - Total Healthcare Cost
Time frame: Baseline up to approximately 8 years
Healthcare Resource Utilization - Percentage of Participants Who Are Hospitalized
Time frame: Baseline up to approximately 8 years
Healthcare Resource Utilization - Length of Hospitalization
Time frame: Baseline up to approximately 8 years
Healthcare Resource Utilization - Percentage of Participants With Emergency Room Visit
Time frame: Baseline up to approximately 8 years
Healthcare Resource Utilization - Percentage of Participants With Outpatient Visit
Time frame: Baseline up to approximately 8 years
Healthcare Resource Utilization - Cost of Disease Related Out-of-Pocket Healthcare Expenditures
Time frame: Baseline up to approximately 8 years
Healthcare Resource Utilization - Indirect Disease Related Cost
Time frame: Baseline up to approximately 8 years
Healthcare Resource Utilization - Number of Working Hours Missed Among Informal Caregivers due to Disease-Related Caregiving Responsibilities
Time frame: Baseline up to approximately 8 years
Healthcare Resource Utilization - Percentage of Participants Receiving Monetary Social Benefits
Time frame: Baseline up to approximately 8 years