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

Sponsor
Exactis Innovation (Other)
Overall Status
Completed
CT.gov ID
NCT04566458
Collaborator
Knight Therapeutics (Other)
63
Enrollment
8
Locations
7.9
Actual Duration (Months)
7.9
Patients Per Site
1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
63 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Real-World Data Study in HER2+ Metastatic Breast Cancer Patients in Third-Line Therapy
Actual Study Start Date :
Oct 1, 2020
Actual Primary Completion Date :
May 30, 2021
Actual Study Completion Date :
May 30, 2021

Arms and Interventions

Arm 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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.

    3. 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.

    4. 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.

    5. 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.

    6. 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 .

    7. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centre hospitalier universitaire Dr-Georges-L.-Dumont Moncton New Brunswick Canada
    2 The Moncton Hospital Moncton New Brunswick Canada
    3 The Ottawa Hospital Ottawa Ontario Canada
    4 Sunnybrook Health Center Toronto Ontario Canada
    5 CHUM- Centre hospitalier de l'universite de Montreal Montreal Quebec Canada
    6 Jewish General Hospital Montreal Quebec Canada
    7 CHUQ- Centre hospitalier universitaire de Québec Québec Quebec Canada
    8 CHUS-CIUSSS de l'Estrie - CHUS - Hôtel-Dieu and CHUS - Hôpital Fleurimont Sherbrooke Quebec Canada

    Sponsors and Collaborators

    • Exactis Innovation
    • Knight Therapeutics

    Investigators

    • Principal Investigator: Gerald Batist, Exactis Innovation

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Exactis Innovation
    ClinicalTrials.gov Identifier:
    NCT04566458
    Other Study ID Numbers:
    • Exactis-05
    First Posted:
    Sep 28, 2020
    Last Update Posted:
    Oct 7, 2021
    Last Verified:
    Feb 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Exactis Innovation
    HER2 positive
    Real World Data
    Metastatic Breast cancer
    Real World Evidence
    Additional relevant MeSH terms:
    Breast Neoplasms

    Study Results

    No Results Posted as of Oct 7, 2021