See if standardized coaching helps patients stick with abemaciclib

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study evaluates whether standardized patient coaching improves adherence to abemaciclib in routine clinical practice for HR+/HER2- early breast cancer. Participants are women 18 or older who recently started abemaciclib in combination with endocrine therapy and meet other criteria. The intervention consists of standardized coaching, with adherence measured through questionnaires and comparison to routine care. Enrollment is at multiple German centers, led by Institut fuer Frauengesundheit with Lilly Deutschland as a collaborator. The trial does not specify a phase, and eligibility includes consent and absence of pregnancy or contraindications to abemaciclib.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Women age 18 or older at time of ICF signature
* Patients with HRpos/HER2neg early breast cancer who are treated with oral, commercially available prescribed abemaciclib in combination with endocrine therapy. Patients can be included if abemaciclib therapy was started no more than 28 days ago
* Patients treated with abemaciclib according to the SmPC and each center´s medical practice
* Informed consent given prior to the starting study activities

Exclusion Criteria:

* Women who are pregnant or lactating
* Patients with contraindications against abemaciclib according to the current SmPC
* Patients who are not eligible for the study due to severe comorbidities, unavailability or any other relevant reason according to the treating physician

Where it's running

• Klinikum Esslingen, Frauenheilkunde und Geburtshilfe
  Esslingen am Neckar, Baden-Wurttemberg, Germany Recruiting
• MVZ am Klinikum Aschaffenburg GmbH
  Aschaffenburg, Bavaria, Germany Recruiting
• Department of Obstetrics and Gynaecology
  Erlangen, Bavaria, Germany Recruiting
• Klinikum Kulmbach, Brustzentrum
  Kulmbach, Bavaria, Germany Recruiting
• MVZ für Onkologie und Urologie GmbH
  Wilhelmshaven, Lower Saxony, Germany Recruiting
• Evangelisches Klinikum Bergisch Gladbach, Gynäkologie
  Bergisch Gladbach, North Rhine-Westphalia, Germany Recruiting

Study contacts

• Study coordinator: Sponsor's study office
• Email: studien@ifg-erlangen.de
• Phone: +49 15739466438

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Improving outcomes for women with high‑risk HR+ early breast cancer taking abemaciclib

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• Ribociclib plus hormone therapy for HR+/HER2- early breast cancer in Saudi Arabia

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.