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HE11AB/21: Real-world Data in Patients With Breast Cancer Treated With Abemaciclib

Sponsor
Hellenic Cooperative Oncology Group (Other)
Overall Status
Recruiting
CT.gov ID
NCT04985058
Collaborator
(none)
108
Enrollment
1
Location
37.8
Anticipated Duration (Months)
2.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The present study will assess real-world clinical outcomes and adverse events from treatment with endocrine therapy combined with abemaciclib in patients with HR-positive, HER2-negative advanced breast cancer.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Protocol was amended in November 2021, after the recent FDA approval of abemaciclib in the adjuvant setting. On October 12, 2021, FDA approved abemaciclib with endocrine therapy for the adjuvant treatment of adult patients with hormone receptor -positive, HER2-negative, node-positive, early breast cancer at high risk of recurrence and a Ki-67 score ≥20%. Our study will now include real-world data on efficacy and toxicity of abemaciclib in the adjuvant setting as well. 2-negative advanced breast cancer. Patients who are enrolled and the patients to be enrolled will refer to a dedicated online platform (CARE ACROSS platform) where they can register their side-effects of cancer and the treatment received at frequent intervals. Patients will be randomized in the platform in two arms with an allocation 1:1(automatically by the platform). After every report of their side-effects, patients in Arm A will receive an acknowledgement and suggestion to stay in contact with their clinician. After every report of their side- effects, patients in Arm B will receive an acknowledgment and suggestion to stay in contact with their clinician; additionally they will receive personalised support (as a few word text) for each side-effect reported. Clinicians involved in the trial will refer patients (upon enrollment or to those already enrolled) to a dedicated online platform. Patients will sign up by entering their patient ID and their email address (and picking their password for security).

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    108 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Real-world Clinical Outcome and Toxicity Data in Patients With Breast Cancer Treated With Abemaciclib Combined With Endocrine Therapy: the Experience of the Hellenic Cooperative Oncology Group
    Actual Study Start Date :
    Oct 6, 2021
    Anticipated Primary Completion Date :
    May 1, 2024
    Anticipated Study Completion Date :
    Dec 1, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    Patients with breast cancer randomised in arm A of digital platform

    Patients with breast cancer treated with abemaciclib in combination with endocrine treatment and randomised in Arm A of the digital platform. Patients randomised in arm A will receive a an acknowledgement and suggestion to stay in contact with their clinician.
    Patients with breast cancer randomised in arm B of digital platform

    Patients with breast cancer treated with abemaciclib in combination with endocrine treatment and randomised in Arm B of the digital platform. Patients randomised in arm A will receive a an acknowledgement and suggestion to stay in contact with their clinician; additionally they will receive personalised support (as a few word text) for each side-effect reported.

    Outcome Measures

    Primary Outcome Measures

    1. Progression-free survival [Through the completion of the study, for an average of 6 months]

      the time from treatment initiation to either the first documented disease progression or death from any cause

    Secondary Outcome Measures

    1. Overall survival [From date of treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 96 months]

      the time from treatment initiation to patient death or last contact

    2. Efficacy of the digital support through personalised support in patients with BC [Up to 30 months]

    Eligibility Criteria

    Criteria

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

    • Histologically confirmed HR-positive, HER2-negative breast cancer

    • Treated at Hellenic Cooperative Oncology Group (HeCOG)-affiliated departments of oncology

    • 18 years or older

    • Any menopausal status

    • Treatment with abemaciclib in combination with endocrine therapy

    • Any endocrine therapy

    • At least two months of treatment with abemaciclib

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hellenic Oncology Cooperative Group Athens Greece

    Sponsors and Collaborators

    • Hellenic Cooperative Oncology Group

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hellenic Cooperative Oncology Group
    ClinicalTrials.gov Identifier:
    NCT04985058
    Other Study ID Numbers:
    • RWD_abemaciclib
    First Posted:
    Aug 2, 2021
    Last Update Posted:
    May 20, 2022
    Last Verified:
    Jan 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Hellenic Cooperative Oncology Group
    abemaciclib
    real-world data
    Additional relevant MeSH terms:
    Breast Neoplasms

    Study Results

    No Results Posted as of May 20, 2022