Clinical trial NCT04566458: RWD Study in HER2+ mBC Patients in Third-Line Therapy
Official title: Real-World Data Study in HER2+ Metastatic Breast Cancer Patients in Third-Line Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer Stage IV
Keywords: HER2 positive
Real World Data
Metastatic Breast cancer
Real World Evidence
Lead sponsor: Exactis Innovation
Sponsor class: OTHER
Collaborators: name: Knight Therapeutics
First posted: 2020-09-28
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population in this study will include up to 100 patients with HER2+ mBC having completed at least two previous lines of anti-HER2 based therapy or a combination of anti-HER2 based therapy and chemotherapy and ongoing third or additional lines of treatment.

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.

Eligibility criteria: 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

Primary outcomes:
measure: To describe treatment sequences of all lines of therapy received by HER2 + mBC patients in Canada
timeFrame: up to 2 years
measure: To describe the brain metastatic HER2+ mBC subpopulation during third line
timeFrame: up to 2 years
measure: To describe radiation therapies received for brain metastasis in HER2+ mBC during third line.
timeFrame: up to 2 years
measure: To calculate the median overall survival (OS) of HER2+ mBC patients who received third-line therapy in Canada.
timeFrame: up to 2 years
measure: To calculate the median PFS of HER2+ mBC patients receiving third-line therapy in Canada
timeFrame: up to 2 years
measure: To calculate the median time to next active anticancer treatment of HER2+ mBC patients receiving third-line therapy in Canada
timeFrame: up to 2 years
measure: To assess HRU for HER2+ mBC patients in Canada during third-line therapy.
timeFrame: up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Moncton
country: Canada
facility: Centre hospitalier universitaire Dr-Georges-L.-Dumont
state: New Brunswick
city: Moncton
country: Canada
facility: The Moncton Hospital
state: New Brunswick
city: Ottawa
country: Canada
facility: The Ottawa Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Center
state: Ontario
city: Montreal
country: Canada
facility: CHUM- Centre hospitalier de l'universite de Montreal
state: Quebec
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Québec
country: Canada
facility: CHUQ- Centre hospitalier universitaire de Québec
state: Quebec
city: Sherbrooke
country: Canada
facility: CHUS-CIUSSS de l'Estrie - CHUS - Hôtel-Dieu and CHUS - Hôpital Fleurimont
state: Quebec
Study officials:
affiliation: Exactis Innovation
name: Gerald Batist
role: PRINCIPAL_INVESTIGATOR
References: