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

Real-World Data Study in HER2+ Metastatic Breast Cancer 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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer Stage IV
• Intervention / Treatment: Other: No intervention

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.

• Study Type: Observational
• Enrollment (Actual): 63

Contacts and Locations

Study Locations

• Canada
  • New Brunswick
    • Moncton, New Brunswick, Canada
      • The Moncton Hospital
    • Moncton, New Brunswick, Canada
      • Centre Hospitalier Universitaire Dr-Georges-L.-Dumont
  • Ontario
    • Ottawa, Ontario, Canada
      • The Ottawa Hospital
    • Toronto, Ontario, Canada
      • Sunnybrook Health Center
  • Quebec
    • Montreal, Quebec, Canada
      • Jewish General Hospital
    • Montreal, Quebec, Canada
      • CHUM- Centre hospitalier de l'Université de Montréal
    • Québec, Quebec, Canada
      • CHUQ- Centre hospitalier universitaire de Québec
    • Sherbrooke, Quebec, Canada
      • CHUS-CIUSSS de l'Estrie - CHUS - Hôtel-Dieu and CHUS - Hôpital Fleurimont

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Single arm; Her2 positive mBC patients who have received at least 3 lines of treatment in the metastatic setting.	Other: No intervention; retrospective chart review study; Other Names: No treatment was administered

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Exactis Innovation
• Collaborators: Knight Therapeutics
• Investigators: Principal Investigator: Gerald Batist, Exactis Innovation

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): May 30, 2021
• Study Completion (Actual): May 30, 2021

Study Registration Dates

• First Submitted: September 22, 2020
• First Submitted That Met QC Criteria: September 22, 2020
• First Posted (Actual): September 28, 2020

Study Record Updates

• Last Update Posted (Actual): October 7, 2021
• Last Update Submitted That Met QC Criteria: October 6, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Real World Evidence; HER2 positive; Real World Data; Metastatic Breast cancer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: Exactis-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No