Human Epidermal Growth Factor Receptor 2 (HER2) Positive Unresectable Locally Advanced or Metastatic Breast Cancer Disease Registry Study

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 the different anticancer treatment regimens and their sequencing throughout the course of the disease in participants with unresectable locally advanced breast cancer (LABC) or metastatic breast cancer (mBC) and to describe the clinical outcome for each treatment regimen measured as progression-free survival.

Official Title
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UK - A 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

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Initially diagnosed with HER2-positive unresectable LABC or mBC no more than 6 months prior to enrollment, although they can have received anti-cancer treatment during that time Able and willing to provide written informed consent and to comply with the study protocol Exclusion Criteria: - There are no exclusion criteria for entry into this study

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 |
| --- | --- |
| Participants With HER2-Positive Breast Cancer<br>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. | Other: No intervention<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | Tumor response will be evaluated by the Investigator according to site-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) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival (OS) |  | From the date of initiation of treatment to the date of death from any cause (up to approximately 8 years) | 
| Percentage of Participants With Objective Response of Complete Response (CR) or Partial Response (PR) | Tumor response will be evaluated by the Investigator according to site-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-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) | 
| Time to Treatment Failure |  | From the date of initiation of treatment to the date of treatment stopped or switched or death from any cause (up to approximately 8 years) | 
| Percentage of Participants With Central Nervous System (CNS) as First Site of Progression |  | From the date of initiation of treatment to the date of disease progression or death from any cause (up to approximately 8 years) | 
| Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) |  | Baseline up to approximately 8 years | 
| Percentage of Participants by Reasons for Treatment Modification |  | Baseline up to approximately 8 years | 
| Percentage of Participants Receiving Each Treatment Regimen Categorized by Participant Characteristics |  | Baseline up to approximately 8 years | 
| Number of Treatment Regimens Received |  | Baseline up to approximately 8 years | 
| Euro Quality of Life 5-Dimension Questionnaire (EQ-5D) Score |  | Baseline up to approximately 8 years (assessed every 3 months) | 
| Functional Assessment of Cancer Therapy-Breast (FACT-B) Questionnaire Score |  | Baseline up to approximately 8 years (assessed every 3 months) | 
| Work Productivity and Activity Impairment (WPAI) Questionnaire Score |  | Baseline up to approximately 8 years (assessed every 3 months) | 
| Percentage of Participants with Different Anti-Cancer Treatment Regimens by Country |  | Baseline up to approximately 8 years | 
| Percentage of Participants with History of Breast Cancer by Different Anti-Cancer Treatment Regimens |  | Baseline up to approximately 8 years | 
| Percentage of Participants with CNS-only Disease Progression |  | From the date of initiation of treatment to the date of disease progression or death from any cause (up to approximately 8 years) | 
| Percentage of Participants with Oligometastatic Disease Categorized by Different Anti-Cancer Treatment Regimens |  | Baseline up to approximately 8 years |