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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04566458

Enrollment

Registered

2020-09-28

Start date

2020-10-01

Completion date

2021-05-30

Last updated

2021-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer Stage IV

Keywords

HER2 positive, Real World Data, Metastatic Breast cancer, Real World Evidence

Brief summary

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

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.

Interventions

OTHERNo intervention

retrospective chart review study

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
To describe treatment sequences of all lines of therapy received by HER2 + mBC patients in Canada	up to 2 years	The proportion of each type of treatment received for all lines of therapy in the metastatic setting will be determined.
To describe the brain metastatic HER2+ mBC subpopulation during third line	up to 2 years	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.
To describe radiation therapies received for brain metastasis in HER2+ mBC during third line.	up to 2 years	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.
To calculate the median overall survival (OS) of HER2+ mBC patients who received third-line therapy in Canada.	up to 2 years	The 2-year survival rate and median OS in third-line HER2+ mBC patients will be quantified.
To calculate the median PFS of HER2+ mBC patients receiving third-line therapy in Canada	up to 2 years	The median PFS in third-line HER2+ mBC patients will be quantified.
To calculate the median time to next active anticancer treatment of HER2+ mBC patients receiving third-line therapy in Canada	up to 2 years	The median time to next active anticancer treatment in third-line HER2+ mBC patients will be quantified .
To assess HRU for HER2+ mBC patients in Canada during third-line therapy.	up to 2 years	Information regarding HRU from HER2+ mBC patients in Canada during third-line therapy will be analyzed.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026