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

Breast Cancer Clinical Trial

— HE11AB/21  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04985058
• Other study ID #: RWD_abemaciclib
• Status: Recruiting
• Start date: October 6, 2021
• Est. completion date: December 1, 2024

Study information

• Verified date: February 2023
• Source: Hellenic Cooperative Oncology Group
• Contact: Elena Fountzilas, MD, PhD
• Phone: +306945779709
• Email: FOUNTZILA[@]ONCOGENOME.GR
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: December 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
Greece	Hellenic Oncology Cooperative Group	Athens

Sponsors (1)

Lead Sponsor	Collaborator
Hellenic Cooperative Oncology Group

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Efficacy of the digital support through personalised support in patients with BC		Up to 30 months
Secondary	Toxicity rate	Adverse events from the time from treatment initiation to disease progression, patient death or last contact	Up to 30 months