RecruitingOBSERVATIONAL

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

This study is an observational study looking at how women with a specific kind of early breast cancer continue using their medicine called abemaciclib. This type of cancer is known as HR+/HER2- early breast cancer. The researchers want to understand how many patients keep taking their medication for at least six months after they start. They will do this by reviewing past patient records and therapy information. This study aims to give doctors a better idea of how consistently patients use this important medicine, which can help improve future care for others with this type of cancer. It's not a trial where new treatments are tested; instead, it's about understanding real-life experiences with an existing treatment.

At a glance

Status

Recruiting

Sponsor

Institut fuer Frauengesundheit

Enrolment target

200

Start

19 Feb 2026

Estimated completion

01 Mar 2027

HR+/HER2- Early Breast Cancer

What is this study about?

This study is about understanding how women with a specific type of early breast cancer use their medication. This type of cancer is called HR+/HER2- early breast cancer. Doctors usually recommend a medicine called abemaciclib for some women with this condition because it can help reduce the chances of the cancer coming back. The main goal of this study is to see how many patients actually continue taking their abemaciclib medicine for at least six months after they first start it.

Researchers are not giving out new medicines or special treatments in this study. Instead, they are looking back at existing medical records and information about patients who have already been prescribed abemaciclib. They want to find out how consistently patients have followed their treatment plan. This kind of study helps doctors understand real-world experiences with medicines outside of a controlled trial setting.

Why does this matter? Knowing how many people keep taking their medicine as prescribed for a good period, like six months, helps doctors and healthcare providers understand if there are any common challenges patients face. This information can then be used to find better ways to support patients, ensure they get the full benefit of their treatment, and potentially improve the care for other women with HR+/HER2- early breast cancer in the future.

Key takeaways

This study uses existing records, not new treatments.
It focuses on how consistently women take abemaciclib for HR+/HER2- early breast cancer.
The goal is to understand real-world use of the medicine for at least 6 months.
Findings could help improve future support for breast cancer patients.
Participation involves no direct patient contact or extra appointments.
Your medical care will not be affected by your decision to participate or not.

Who may be eligible?

This study is looking for women aged 18 or older who have been diagnosed with a specific type of early breast cancer called HR+/HER2-. You would need to have been prescribed the medicine abemaciclib as part of your treatment. The study is particularly interested in those who started their abemaciclib treatment between January 1st, 2023, and June 30th, 2025.

There are also some reasons why you wouldn't be able to be part of this study. For example, if your breast cancer has spread to other parts of your body (which doctors call advanced or metastatic breast cancer), you wouldn't be eligible. Also, the study is only for female patients, and you shouldn't have any health reasons that would make taking abemaciclib unsafe for you, based on what your doctor has advised.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you female and aged 18 or older?
Do you have HR+/HER2- early breast cancer?
Were you prescribed the medicine abemaciclib?
Did you start abemaciclib treatment between January 1st, 2023, and June 30th, 2025?
Has your breast cancer not spread to other parts of your body?
Do you have no medical reasons preventing you from taking abemaciclib?

Answer every question to see your result.

What does participation involve?

Since this is an 'observational' study, it’s a bit different from typical clinical trials. You wouldn't need to take any new medicines or attend extra appointments. The researchers are simply looking back at existing medical records. This means you wouldn't have any specific tasks like completing questionnaires, undergoing extra tests, or visiting the clinic more often. Your participation would involve allowing researchers to review your past treatment information related to your abemaciclib prescription. There's no set duration of involvement for you personally, as the data collection is from past records.

Potential risks and benefits

Because this study only involves reviewing past medical records without any direct contact or interventions with patients, there are generally no direct risks or immediate benefits to you as a participant. You won't be taking any new medication or having any procedures. The main benefit is that your anonymised information, when combined with others, can help medical professionals understand how certain treatments are used in the real world, potentially improving future care for patients with breast cancer. You always have the right to withdraw your consent for your data to be used in the study if you change your mind, and this decision would not affect your medical care.

Locations (1)

Department of Obstetrics and Gynaecology, Uniklinikum Erlangen
Verified postcode
Erlangen, Germany· Recruiting

Common questions

What kind of breast cancer is this study about?

It's about a type called HR+/HER2- early breast cancer.

What medicine are they looking at?

The study focuses on a medicine called abemaciclib.

Will I have to take new medicine or attend extra appointments?

No, this study only reviews past medical records; you won't have new treatments or appointments.

Who is eligible to be part of this study?

Women aged 18+ with HR+/HER2- early breast cancer who were prescribed abemaciclib between specific dates.

How does this study help patients?

It helps doctors understand how well patients use their medicines, which can lead to better support and care in the future.

How to find out more

Sponsor's study office

studien@ifg-erlangen.de +49 15739466438 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.