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

May 11, 2026 updated by: Institut fuer Frauengesundheit

Patient Relevant Outcomes Improvement Program in High Risk HR-positive 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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Germany
    • Bavaria
      • Erlangen, Bavaria, Germany, 91054
        • Recruiting
        • Department of Obstetrics and Gynaecology, Uniklinikum Erlangen
        • Principal Investigator:
          • Peter A. Fasching, Prof. Dr. med.
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study 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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
High-risk HR+/HER2- early breast cancer patients
High-risk HR+/HER2- early breast cancer patients under abemaciclib therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Abemaciclib persistence rate
Time Frame: 6 months after therapy start
Abemaciclib persistence rate (defined as ongoing abemaciclib therapy)
6 months after therapy start

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut fuer Frauengesundheit

Collaborators

Lilly Deutschland GmbH Germany
AGO-B Breast Study Group

Investigators

  • Study Chair: Peter A. Fasching, Prof. Dr. med., Department of Obstetrics and Gynaecology, Uniklinikum Erlangen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 19, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

April 9, 2026

First Submitted That Met QC Criteria

April 9, 2026

First Posted (Actual)

April 15, 2026

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • IFG-02-2025

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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