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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants With HER2-Positive Breast Cancer | Enrolled participants will receive treatment and clinical assessments for their HER2-positive unresectable LABC/MBC as determined by their treating physician, according to the standard of care and routine clinical practice at each site. Participants will be followed until death, withdrawal of consent or study termination, whichever occurs first. Study protocol does not specify any particular drug or treatment regimen. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Receiving Each Unique Treatment Regimen Overall | Baseline up to approximately 8 years | |
| Percentage of Participants Receiving Each Unique Treatment Regimen as First-Line Versus Subsequent-Line Therapy | Baseline up to approximately 8 years | |
| Percentage of Participants Receiving Each Unique Treatment Regimen Sequence | 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. | From start date of anti-cancer treatment regimen to the date of either disease progression or death (up to approximately 8 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | Baseline up to approximately 8 years | |
| Percentage of Participants Receiving Each Treatment Regimen, by Participant Characteristics | Baseline up to approximately 8 years |
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Inclusion Criteria:
Exclusion Criteria:
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Disease registry data will be collected among participants with HER2-positive unresectable LABC or MBC.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bank of Cyprus Oncology Center | Nicosia | 2006 | Cyprus | |||
| Anticancer Hospital Ag Savas; 1St Dept of Internal Medicine |
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| Percentage of Participants Receiving Each Treatment Regimen, by Country/Region | Baseline up to approximately 8 years |
| Overall Survival (OS) | 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 | 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. | 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. | 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 | Baseline up to approximately 8 years |
| EuroQoL 5-Dimension 5-Level Questionnaire (EQ-5D-5L) Score | Baseline up to approximately 8 years |
| Functional Assessment of Cancer Therapy-Breast (FACT-B) Questionnaire Score | Baseline up to approximately 8 years |
| Work Productivity and Activity Impairment-General Health (WPAI-GH) Questionnaire Score | Baseline up to approximately 8 years |
| Percentage of Participants With HER2 Retesting | Baseline up to approximately 8 years |
| Percentage of Participants With HER2 Overexpression, as Assessed Using In Situ Hybridization or Immunohistochemistry | Baseline up to approximately 8 years |
| Healthcare Resource Utilization - Total Healthcare Cost | Baseline up to approximately 8 years |
| Healthcare Resource Utilization - Percentage of Participants Who Are Hospitalized | Baseline up to approximately 8 years |
| Healthcare Resource Utilization - Length of Hospitalization | Baseline up to approximately 8 years |
| Healthcare Resource Utilization - Percentage of Participants With Emergency Room Visit | Baseline up to approximately 8 years |
| Healthcare Resource Utilization - Percentage of Participants With Outpatient Visit | Baseline up to approximately 8 years |
| Healthcare Resource Utilization - Cost of Disease Related Out-of-Pocket Healthcare Expenditures | Baseline up to approximately 8 years |
| Healthcare Resource Utilization - Indirect Disease Related Cost | Baseline up to approximately 8 years |
| Healthcare Resource Utilization - Number of Working Hours Missed Among Informal Caregivers due to Disease-Related Caregiving Responsibilities | Baseline up to approximately 8 years |
| Healthcare Resource Utilization - Percentage of Participants Receiving Monetary Social Benefits | Baseline up to approximately 8 years |
| Athens |
| 115 22 |
| Greece |
| Anticancer Hospital Ag. Savas ; 2Nd Dept. of Oncology - Internal Medicine | Athens | 115 22 | Greece |
| ARETAIEION UNIVERSITY HOSPITAL; oncology unit | Athens | 115 28 | Greece |
| 251 Air Force General Hospital-Oncology Clinic | Athens | 11525 | Greece |
| Agioi Anargyroi; 3Rd Dept. of Medical Oncology | Athens | 145 64 | Greece |
| IASO | Athens | 151 23 | Greece |
| IASO General Hospital of Athens | Athens | 155 62 | Greece |
| Attikon University Hospital; 4th Department of Internal Medicine | Haidari | 124 62 | Greece |
| Metropolitan Hospital; 2Nd Oncology Clinic | Piraeus | 185 47 | Greece |
| Theagenio Anticancer Hospital; 3Rd Oncology Clinic | Thessaloniki | 546 39 | Greece |
| Papageorgiou General Hospital; Medical Oncology | Thessaloniki | 564 29 | Greece |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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