Assessing real-world outcomes of abemaciclib in breast cancer patients
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
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 |
|---|---|
| Enrollment | 108 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hellenic Cooperative Oncology Group Academic / other |
| Locations | 1 site (Athens) |
| Trial ID | NCT04985058 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Other studies have shown success with real-world data approaches in oncology, suggesting that this methodology is promising and not entirely novel.
Eligibility criteria
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 this trial is running
Athens
- Hellenic Oncology Cooperative Group — Athens, Greece (Recruiting)
Study contacts
- Study coordinator: Elena Fountzilas, MD, PhD
- Email: FOUNTZILA@ONCOGENOME.GR
- Phone: +306945779709
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.