RWD Study in HER2+ mBC Patients in Third-Line Therapy

Study Overview
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Brief Summary
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This retrospective observational study will collect Canadian real-world data (RWD) from HER2+ metastatic breast cancer (mBC) patients to describe treatment sequences of all therapies received in the metastatic setting, to measure overall survival (OS), progression free survival (PFS), time to next active anti-cancer therapy, and to estimate the health resources utilization (HRU) during third-line therapy.

Detailed Description
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The proportion of treatment received during all lines of therapy in the metastatic setting will be described. The 2-year survival rate and median OS with interquartile range (IQR) for third-line therapy will be calculated. HRU data and costs during third-line therapy will be collected.

Official Title
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Real-World Data Study in HER2+ Metastatic Breast Cancer Patients in Third-Line Therapy

Conditions
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Breast Cancer Stage IV

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patients (≥18 years of age) Patients with stage IV breast cancer Patients with HER2+ status in metastatic setting Patients that received at least two lines of active anti-cancer drugs due to disease progression. Patients that began third-line therapy prior to October 31, 2018. Exclusion Criteria: Patients treated with an investigational anticancer agent in the ≥ 3rd line setting

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 |
| --- | --- |
| Single arm<br>Her2 positive mBC patients who have received at least 3 lines of treatment in the metastatic setting. | Other: No intervention<br>* retrospective chart review study<br>* Other names: No treatment was administered;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To describe treatment sequences of all lines of therapy received by HER2 + mBC patients in Canada | The proportion of each type of treatment received for all lines of therapy in the metastatic setting will be determined. | up to 2 years | 
| To describe the brain metastatic HER2+ mBC subpopulation during third line | The proportion of HER2+ mBC having brain metastasis at start of third lineas well as number of patients developing brain metastasis during third line will be quantified. | up to 2 years | 
| To describe radiation therapies received for brain metastasis in HER2+ mBC during third line. | The proportion of each type of radiation therapy received during third line, the time between brain metastasis detection and whole brain radiation (WBR), and the proportion of patients receiving a second WBR before death will be quantified. | up to 2 years | 
| To calculate the median overall survival (OS) of HER2+ mBC patients who received third-line therapy in Canada. | The 2-year survival rate and median OS in third-line HER2+ mBC patients will be quantified. | up to 2 years | 
| To calculate the median PFS of HER2+ mBC patients receiving third-line therapy in Canada | The median PFS in third-line HER2+ mBC patients will be quantified. | up to 2 years | 
| To calculate the median time to next active anticancer treatment of HER2+ mBC patients receiving third-line therapy in Canada | The median time to next active anticancer treatment in third-line HER2+ mBC patients will be quantified . | up to 2 years | 
| To assess HRU for HER2+ mBC patients in Canada during third-line therapy. | Information regarding HRU from HER2+ mBC patients in Canada during third-line therapy will be analyzed. | up to 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HER2 positive, Real World Data, Metastatic Breast cancer, Real World Evidence