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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

63 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-01

Study Completion Date

2021-05-30

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.

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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.

Conditions

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Breast Cancer Stage IV

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Single arm

Her2 positive mBC patients who have received at least 3 lines of treatment in the metastatic setting.

No intervention

Intervention Type OTHER

retrospective chart review study

Interventions

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No intervention

retrospective chart review study

Intervention Type OTHER

Other Intervention Names

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No treatment was administered

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.