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

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Breast Cancer

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with breast cancer randomised in arm A of digital platform<br>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<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival | the time from treatment initiation to either the first documented disease progression or death from any cause | Through the completion of the study, for an average of 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | The time from treatment initiation to patient death or last contact | 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 | 
| Efficacy of the digital support through personalised support in patients with BC |  | Up to 30 months | 
| Toxicity rate | Adverse events from the time from treatment initiation to disease progression, patient death or last contact | Up to 30 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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abemaciclib, real-world data