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

Breast Cancer Stage IV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04566458
• Other study ID #: Exactis-05
• Status: Completed
• Start date: October 1, 2020
• Est. completion date: May 30, 2021

Study information

• Verified date: February 2021
• Source: Exactis Innovation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: May 30, 2021
• Est. primary completion date: May 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer Stage IV
• Breast Neoplasms

Intervention

Other:
• No intervention
retrospective chart review study

Locations

Country	Name	City	State
Canada	Centre hospitalier universitaire Dr-Georges-L.-Dumont	Moncton	New Brunswick
Canada	The Moncton Hospital	Moncton	New Brunswick
Canada	CHUM- Centre hospitalier de l'universite de Montreal	Montreal	Quebec
Canada	Jewish General Hospital	Montreal	Quebec
Canada	The Ottawa Hospital	Ottawa	Ontario
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	Sunnybrook Health Center	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Exactis Innovation	Knight Therapeutics

Country where clinical trial is conducted

Canada, 

Outcome

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