Real-world Data in Patients With Breast Cancer Treated With Abemaciclib

Recruiting

• Conditions: Breast Cancer

• Registration Number: NCT04985058
• Lead Sponsor: Hellenic Cooperative Oncology Group

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.

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 Timeline

• Study First Submitted: 2021-07-26
• Study First Submitted QC: 2021-07-26
• Study First Posted: 2021-08-02
• Study Start: 2021-10-06
• Status Verified: 2024-10
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-18
• Primary Completion: 2026-11-30
• Study Completion: 2027-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 108

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Toxicity rate	Up to 30 months	Adverse events from the time from treatment initiation to disease progression, patient death or last contact
Efficacy of the digital support through personalised support in patients with BC	Up to 30 months

Trial Locations

Locations (1)

Hellenic Oncology Cooperative Group; 🇬🇷 Athens, Greece