Recruiting NCT07531693
Patient Relevant Outcomes Improvement Program in High Risk Hormone Receptor Positive (HR+) Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: HR+/HER2- Early Breast Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Patient Relevant Outcomes Improvement Program in High Risk HR-positive Breast Cancer
Overview
The goal of this observational study is to evaluate how persistently patients with high-risk early breast cancer take abemaciclib 6 months after therapy start. To this end, researchers will perform a retrospective analysis of therapy data.
Primary outcome measures
- Abemaciclib persistence rate [Time frame: 6 months after therapy start]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- Department of Obstetrics and Gynaecology, Uniklinikum Erlangen — Erlangen
Identifiers
NCT: NCT07531693 · IFG-02-2025