HR+/HER2- Early Breast CancerPROSPERNCT07531693
Patient Relevant Outcomes Improvement Program in High Risk Hormone Receptor Positive (HR+) Breast Cancer
An observational study of HR+/HER2- Early Breast Cancer, run by Institut fuer Frauengesundheit at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HR+/HER2- Early Breast Cancer
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- 19 Feb 2026to Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Locally advanced or metastatic breast cancer
- Male patients
- Patients with contraindication(s) for abemaciclib therapy according to SmPC
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Department of Obstetrics and Gynaecology, Uniklinikum Erlangen
Erlangen, Bavaria, 91054
Study Center, +49 9131 8533572, fk-studienzentrale@uk-erlangen.de
Peter A. Fasching, Prof. Dr. med.
About this study
Official title: 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.
- Conditions
- HR+/HER2- Early Breast Cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| High-risk HR+/HER2- early breast cancer patients | High-risk HR+/HER2- early breast cancer patients under abemaciclib therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abemaciclib persistence rate
Abemaciclib persistence rate (defined as ongoing abemaciclib therapy)
Measured: 6 months after therapy start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2026
- Study start19 Feb 2026
- Primary completionSep 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HR+/HER2- Early Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut fuer Frauengesundheit
- Sponsor type
- University, hospital or other
- Collaborators
- Lilly Deutschland GmbH Germany, AGO-B Breast Study Group
- Responsible party
- Sponsor
- Investigators
- Peter A. Fasching, Prof. Dr. med., Study chair, Department of Obstetrics and Gynaecology, Uniklinikum Erlangen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07531693
- Sponsor's protocol ID
- IFG-02-2025
- Acronym
- PROSPER
- Status last verified
- May 2026
- First submitted
- 9 Apr 2026
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Relevant Outcomes Improvement Program in High Risk HR-positive Breast Cancer
- ClinicalTrials.gov ID
- NCT07531693
- Acronym / sponsor ID
- PROSPER / IFG-02-2025
- Conditions
- HR+/HER2- Early Breast Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Institut fuer FrauengesundheitUniversity, hospital or other
- Collaborators
- Lilly Deutschland GmbH Germany, AGO-B Breast Study Group
- Study start
- 19 Feb 2026 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 15 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High-risk HR+/HER2- early breast cancer patients | – | –High-risk HR+/HER2- early breast cancer patients under abemaciclib therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Locally advanced or metastatic breast cancer
- Male patients
- Patients with contraindication(s) for abemaciclib therapy according to SmPC
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Abemaciclib persistence rate
Time frame: 6 months after therapy start
Abemaciclib persistence rate (defined as ongoing abemaciclib therapy)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peter A. Fasching, Prof. Dr. med. study chair
Department of Obstetrics and Gynaecology, Uniklinikum Erlangen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HR+/HER2- Early Breast Cancer, run by Institut fuer Frauengesundheit at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sponsor's study office (+49 15739466438, studien@ifg-erlangen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abemaciclib persistence rate (time frame: 6 months after therapy start). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026; AzTrials last refreshed its copy on 26 Oct 2026.