Assessing real-world outcomes of abemaciclib in breast cancer patients
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
Run by Hellenic Cooperative Oncology Group · NCT04985058 · Data updated 2026-11-12
This study is testing how well a drug called abemaciclib works for people with advanced breast cancer and what side effects they experience while using it alongside other treatments.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 108 (estimated) |
| Sponsor | Hellenic Cooperative Oncology Group Academic / other |
| Locations | 1 site (Athens) |
| Status | Recruiting |
| Started | October 6, 2021 |
| Main results expected | November 30, 2026 |
| Study ends | July 1, 2027 |
| Registry record updated | July 21, 2026 |
| Trial ID | NCT04985058 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults aged 18 and older with histologically confirmed HR-positive, HER2-negative breast cancer who are receiving abemaciclib in combination with endocrine therapy.
✕Probably not a fit
Patients with breast cancer who are not receiving abemaciclib or those with HER2-positive or HR-negative tumors may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the real-world clinical outcomes and adverse events associated with the use of abemaciclib in combination with endocrine therapy for patients with HR-positive, HER2-negative advanced breast cancer. Following the FDA's approval of abemaciclib for adjuvant treatment, the study will gather data on efficacy and toxicity in both advanced and early breast cancer settings. Patients will report their side effects through a dedicated online platform, where they will be randomized into two arms to receive different levels of support based on their reports. The study aims to enhance understanding of treatment experiences in a real-world context.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the effectiveness and safety of abemaciclib, potentially improving treatment strategies for breast cancer patients.
How similar studies have gone: Other studies have shown success with real-world data approaches in oncology, suggesting that this methodology is promising and not entirely novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Hellenic Oncology Cooperative Group
Athens, Greece Recruiting
Study contacts
- Study coordinator: Elena Fountzilas, MD, PhD
- Email: FOUNTZILA@ONCOGENOME.GR
- Phone: +306945779709
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.