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

NCT ID: NCT04985058

Last Updated: 2025-05-18

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 108 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-10-06
• Study Completion Date: 2027-07-01

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).

Conditions

Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hellenic Cooperative Oncology Group

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hellenic Oncology Cooperative Group

Athens, , Greece

Site Status: RECRUITING

Countries

Greece

Central Contacts

Elena Fountzilas, MD, PhD

Role: CONTACT

FOUNTZILA@ONCOGENOME.GR

+306945779709

Areti Stamboliou

Role: CONTACT

a_stampoliou@hecog.ondsl.gr

+302106912520 ext. 23

Facility Contacts

Elena Fountzilas, MD

Role: primary

fountzila@oncogenome.gr

References

Fountzilas E, Aravantinou-Fatorou E, Dadouli K, Economopoulou P, Tryfonopoulos D, Vernadou A, Vorrias E, Vagionas A, Nikolaidi A, Karageorgopoulou S, Koumarianou A, Boukovinas I, Mauri D, Kokkali S, Christopoulou A, Tsoukalas N, Assi A, Spathas N, Kosmidis P, Koutras A, Fountzilas G, Psyrri A. Real-World Toxicity and Effectiveness Study of Abemaciclib in Greek Patients with Hormone Receptor-Positive/Human Epidermal Growth Factor Receptor 2-Negative Breast Cancer: A Multi-Institutional Study. Cancers (Basel). 2025 Jul 31;17(15):2543. doi: 10.3390/cancers17152543.

Reference Type: DERIVED

PMID: 40805239 (View on PubMed)

Other Identifiers

RWD_abemaciclib

Identifier Type: -

Identifier Source: org_study_id