Clinical trial Recruiting at 1 site Observational Ages 18 and up

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.

More Breast Cancer trials

Quick facts

Study typeObservational
Ages18 Years and up
SexAll
Enrollment108 (estimated)
SponsorHellenic Cooperative Oncology Group
Academic / other
Locations1 site (Athens)
StatusRecruiting
StartedOctober 6, 2021
Main results expectedNovember 30, 2026
Study endsJuly 1, 2027
Registry record updatedJuly 21, 2026
Trial IDNCT04985058 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.