RWD Study in HER2+ mBC Patients in Third-Line Therapy
- Conditions
- Breast Cancer Stage IV
- Interventions
- Other: No intervention
- Registration Number
- NCT04566458
- Lead Sponsor
- Exactis Innovation
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 63
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.
Patients treated with an investigational anticancer agent in the ≥ 3rd line setting
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Single arm No intervention Her2 positive mBC patients who have received at least 3 lines of treatment in the metastatic setting.
- Primary Outcome Measures
Name Time Method 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 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 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 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.
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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (8)
The Moncton Hospital
🇨🇦Moncton, New Brunswick, Canada
The Ottawa Hospital
🇨🇦Ottawa, Ontario, Canada
CHUM- Centre hospitalier de l'universite de Montreal
🇨🇦Montreal, Quebec, Canada
Sunnybrook Health Center
🇨🇦Toronto, Ontario, Canada
Jewish General Hospital
🇨🇦Montreal, Quebec, Canada
CHUQ- Centre hospitalier universitaire de Québec
🇨🇦Québec, Quebec, Canada
CHUS-CIUSSS de l'Estrie - CHUS - Hôtel-Dieu and CHUS - Hôpital Fleurimont
🇨🇦Sherbrooke, Quebec, Canada
Centre hospitalier universitaire Dr-Georges-L.-Dumont
🇨🇦Moncton, New Brunswick, Canada