Patient Relevant Outcomes Improvement Program in High Risk Hormone Receptor Positive (HR+) Breast Cancer

ConditionHR+/HER2- Early Breast Cancer

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexFemale

Age18+

SponsorInstitut fuer Frauengesundheit

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Locally advanced or metastatic breast cancer

Male patients

Patients with contraindication(s) for abemaciclib therapy according to SmPC

Trial population

Patients will be selected from up to 30 study sites across Germay. Sites will be selected from certified breast cancer centers that have experience providing adjuvant treatment to breast cancer patients.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

200 Participants

are grouped into 1 trial group

Group A: High-risk HR+/HER2- early breast cancer patients

Trial outcomes

Primary outcomes

Abemaciclib persistence rate

Abemaciclib persistence rate (defined as ongoing abemaciclib therapy)

Time frame

6 months after therapy start

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institut fuer Frauengesundheit

Lead sponsor

Lilly Deutschland GmbH Germany

Collaborator

AGO-B Breast Study Group

Collaborator

Source ClinicalTrials.gov

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