RWD Study in HER2+ mBC Patients in Third-Line Therapy
Real-World Data Study in HER2+ Metastatic Breast Cancer Patients in Third-Line Therapy
1 other identifier
observational
63
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2020
Shorter than P25 for all trials
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 22, 2020
CompletedFirst Posted
Study publicly available on registry
September 28, 2020
CompletedStudy Start
First participant enrolled
October 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2021
CompletedOctober 7, 2021
February 1, 2021
8 months
September 22, 2020
October 6, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (7)
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
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
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
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
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
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
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
Study Arms (1)
Single arm
Her2 positive mBC patients who have received at least 3 lines of treatment in the metastatic setting.
Interventions
retrospective chart review study
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- Patients treated with an investigational anticancer agent in the ≥ 3rd line setting
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Exactis Innovationlead
- Knight Therapeuticscollaborator
Study Sites (8)
Centre hospitalier universitaire Dr-Georges-L.-Dumont
Moncton, New Brunswick, Canada
The Moncton Hospital
Moncton, New Brunswick, Canada
The Ottawa Hospital
Ottawa, Ontario, Canada
Sunnybrook Health Center
Toronto, Ontario, Canada
CHUM- Centre hospitalier de l'universite de Montreal
Montreal, Quebec, 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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gerald Batist
Exactis Innovation
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 22, 2020
First Posted
September 28, 2020
Study Start
October 1, 2020
Primary Completion
May 30, 2021
Study Completion
May 30, 2021
Last Updated
October 7, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will share
The results of this retrospective observational study will not be formally documented in a Clinical Study Report. Coded patient-level data will be shared with the sponsor.