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NCT Number: NCT04566458

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

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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Key information

Conditions

Breast Cancer Stage IV Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre hospitalier universitaire Dr-Georges-L.-Dumont, Moncton, New Brunswick, Canada

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

retrospective chart review study

Other names: No treatment was administered

Primary outcomes

  1. To describe treatment sequences of all lines of therapy received by HER2 + mBC patients in Canada

    Time frame: up to 2 years

    The proportion of each type of treatment received for all lines of therapy in the metastatic setting will be determined.

  2. To describe the brain metastatic HER2+ mBC subpopulation during third line

    Time frame: 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.

  3. To describe radiation therapies received for brain metastasis in HER2+ mBC during third line.

    Time frame: 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.

  4. To calculate the median overall survival (OS) of HER2+ mBC patients who received third-line therapy in Canada.

    Time frame: up to 2 years

    The 2-year survival rate and median OS in third-line HER2+ mBC patients will be quantified.

  5. To calculate the median PFS of HER2+ mBC patients receiving third-line therapy in Canada

    Time frame: up to 2 years

    The median PFS in third-line HER2+ mBC patients will be quantified.

  6. To calculate the median time to next active anticancer treatment of HER2+ mBC patients receiving third-line therapy in Canada

    Time frame: up to 2 years

    The median time to next active anticancer treatment in third-line HER2+ mBC patients will be quantified .

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

    Time frame: up to 2 years

    Information regarding HRU from HER2+ mBC patients in Canada during third-line therapy will be analyzed.

Sponsors and collaborators

Lead sponsor

Exactis Innovation

Other

Collaborators

  • Knight Therapeutics

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 28, 2020
Registry last updated
Oct 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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