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

Exactis Innovation63 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Breast Cancer Stage IV

Interventions

No interventionOTHER

retrospective chart review study

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (8)

Centre hospitalier universitaire Dr-Georges-L.-Dumont

Moncton, New Brunswick, Canada

The Moncton Hospital

Moncton, New Brunswick, Canada

The Ottawa Hospital

Ottawa, Ontario, Canada

Sunnybrook Health Center

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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 .

Time frame: up to 2 years

To assess HRU for HER2+ mBC patients in Canada during third-line therapy.

Data from ClinicalTrials.gov

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