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

NCT04985058 | Recruiting

• 1 other identifier: RWD_abemaciclib
• Study Type: observational
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

abemaciclib; real-world data

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• Efficacy of the digital support through personalised support in patients with BC

  Up to 30 months

• Toxicity rate

  Up to 30 months

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with histologically confirmed HR-positive, HER2-negative breast cancer treated with abemaciclib in combination with endocrine therapy

You may qualify if:

• Histologically confirmed HR-positive, HER2-negative breast cancer
• Treated at Hellenic Cooperative Oncology Group (HeCOG)-affiliated departments of oncology
• 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

Sponsors & Collaborators

• Hellenic Cooperative Oncology Group: lead

Study Sites (1)

Hellenic Oncology Cooperative Group

Athens, Greece

RECRUITING

Related Publications (1)

• 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.

  PMID: 40805239 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Elena Fountzilas, MD, PhD

CONTACT

+306945779709; FOUNTZILA@ONCOGENOME.GR

Areti Stamboliou

CONTACT

+302106912520; a_stampoliou@hecog.ondsl.gr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2021
• First Posted: August 2, 2021
• Study Start: October 6, 2021
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: May 18, 2025

Record last verified: 2024-10

Locations

GR (1)