Improving outcomes for women with high‑risk HR+ early breast cancer taking abemaciclib
Official title: Patient Relevant Outcomes Improvement Program in High Risk HR-positive Breast Cancer
Run by Institut fuer Frauengesundheit · NCT07531693 · Data updated 2026-11-12
This project looks back at medical records to see if women with high‑risk HR+/HER2‑ early breast cancer are still taking abemaciclib six months after they start treatment.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 200 (estimated) |
| Sponsor | Institut fuer Frauengesundheit Academic / other |
| Locations | 1 site (Erlangen, Bavaria) |
| Status | Recruiting |
| Started | February 19, 2026 |
| Main results expected | January 2027 |
| Study ends | June 2027 |
| Registry record updated | November 6, 2026 |
| Trial ID | NCT07531693 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 18 or older with confirmed HR+/HER2‑ early breast cancer who were prescribed abemaciclib between January 1, 2023 and June 30, 2025 and have no distant metastases or contraindications are the ideal candidates for inclusion.
✕Probably not a fit
Male patients, people with locally advanced or metastatic breast cancer, and patients who never started abemaciclib would not be included and would not directly benefit from the study findings.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a retrospective observational analysis of treatment records to measure persistence with abemaciclib among women with high‑risk HR+/HER2‑ early breast cancer. The study will include patients aged 18 or older who started abemaciclib between January 1, 2023 and June 30, 2025 and were treated according to the product labeling. Patients with distant metastases, male patients, or those with documented contraindications to abemaciclib are excluded. Data will be drawn from the Uniklinikum Erlangen site and analyzed to determine the proportion of patients still on therapy six months after initiation and to describe reasons for discontinuation where available.
Why it matters
Potential benefit: If the study identifies early discontinuation patterns, clinicians and care teams could target support to improve treatment persistence and potentially improve outcomes.
How similar studies have gone: Real‑world adherence and persistence studies of CDK4/6 inhibitors have reported variable persistence, but retrospective data specifically focused on abemaciclib in high‑risk early HR+ disease remain limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Femal patients age 18 or older at time of informed consent * Confirmed diagnosis of HR+/HER2- early breast cancer (no distant metastasis) * Prescribed abemaciclib therapy according to the Summary of Product Characteristics (SmPC) * Abemaciclib therapy occured between January 1st, 2023 and June 30th, 2025 Exclusion Criteria: * Locally advanced or metastatic breast cancer * Male patients * Patients with contraindication(s) for abemaciclib therapy according to SmPC
Where it's running
-
Department of Obstetrics and Gynaecology, Uniklinikum Erlangen
Erlangen, Bavaria, Germany Recruiting
Study contacts
- Study coordinator: Sponsor's study office
- Email: prosper@ifg-erlangen.de
- Phone: +49 9131 91880613
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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.