Recruiting

NCT Number: NCT07531693

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

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.

Recruiting

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Key information

Conditions

HR+/HER2- Early Breast Cancer

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Department of Obstetrics and Gynaecology, Uniklinikum Erlangen

Erlangen, Bavaria, 91054, Germany

Location status: Recruiting

Location contact

Peter A. Fasching, Prof. Dr. med.

PRINCIPAL_INVESTIGATOR

Study Center

CONTACT

[email protected]

+49 9131 8533572

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Abemaciclib persistence rate

Time frame: 6 months after therapy start

Abemaciclib persistence rate (defined as ongoing abemaciclib therapy)

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsor's study office

CONTACT

[email protected]

+49 15739466438

Sponsors and collaborators

Lead sponsor

Institut fuer Frauengesundheit

Other

Collaborators

AGO-B Breast Study Group
Lilly Deutschland GmbH Germany

Registry information

Official study title

Patient Relevant Outcomes Improvement Program in High Risk HR-positive Breast Cancer

Acronym: PROSPER

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2027
First posted: Apr 15, 2026
Registry last updated: May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Recruiting