A European Registry Study to Prospectively Observe Treatment Patterns and Outcomes in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Unresectable Locally Advanced (LA) or Metastatic Breast Cancer (mBC) (SAMANTHA)

Study Overview
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Brief Summary
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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 LA/mBC. Diagnosis of unresectable LA or mBC can be up to 6 months old prior to registry enrollment.

Official Title
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A European Disease Registry Study to Prospectively Observe Treatment Patterns and Outcomes in Patients With HER2-Positive Unresectable Locally Advanced or Metastatic Breast Cancer

Conditions
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Breast Cancer

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Initially diagnosed with HER2-positive unresectable LA/mBC no more than 6 months prior to enrollment, although they can have received anti-cancer treatment during that time Exclusion Criteria: - Not applicable

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HER2-positive unresectable LA/mBC<br>Participants with HER2-positive unresectable LA/mBC diagnosed up to 6 months prior to enrollment will be included in the study. Enrolled participants will receive treatment and clinical assessments for their HER2-positive unresectable LA/mBC as determined by their treating physician, according to the standard of care and routine clinical practice at each site. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free Survival per Anti-cancer Treatment Regimens Assessed According to Site-/Country-Specific Medical Practice |  | Baseline up to 8 years | 
| Percentage of Participants by Different Anti-cancer Treatment Regimens and Treatment Sequences |  | Baseline up to 8 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | Baseline up to 8 years | 
| Duration of Response per Anti-cancer Treatment Regimens Assessed According to Site-/Country-Specific Medical Practice |  | Baseline up to 8 years | 
| Percentage of Participants with Best Overall Response of Complete Response (CR) or Partial Response (PR) per Anti-cancer Treatment Regimens Assessed According to Site-/Country-Specific Medical Practice |  | Baseline up to 8 years | 
| Total Number of Treatment Regimens Received by Participants |  | Baseline up to 8 years | 
| Percentage of Participants with Adverse Events (AEs), Serious AEs, and Protocol-defined AEs of Special Interest |  | Baseline up to 8 years | 
| Percentage of Participants with HER2 Re-testing of Metastases |  | Baseline up to 8 years | 
| Percentage of Participants with Change in HER2 Status |  | Baseline up to 8 years | 
| Percentage of Participants by Type of HER2 Testing (Immunohistochemistry and/or Fluorescence In situ Hybridization [FISH]) |  | Baseline up to 8 years | 
| Percentage of Participants with Different Anti-Cancer Treatment Regimens by Country |  | Baseline up to 8 years | 
| Percentage of Participants with History of Breast Cancer by Different Anti-Cancer Treatment Regimens |  | Baseline up to 8 years | 
| EuroQol 5-Dimensions Questionnaire (EQ-5D) Score |  | Baseline up to 8 years | 
| Functional Assessment of Cancer Therapy-Breast (FACT-B) Questionnaire Score |  | Baseline up to 8 years | 
| Total Healthcare Cost |  | Baseline up to 8 years | 
| Cost of Treating Associated AEs |  | Baseline up to 8 years | 
| Resource Utilization: Percentage of Participants with Breast Cancer Associated Procedures |  | Baseline up to 8 years | 
| Resource Utilization: Percentage of Participants with Hospitalization |  | Baseline up to 8 years | 
| Resource Utilization: Percentage of Participants with Emergency Room Attendances and Outpatient Visits |  | Baseline up to 8 years |