RecruitingNCT06650423

Adherence to Aromatase Inhibitors ± Abemaciclib Treatment in Patients With Early-stage HER2-negative Breast Cancer

ONCO-ADHER: Adherence to Treatment With Aromatase Inhibitors With or Without Abemaciclib in Patients With Early-stage, Endocrine-dependent, HER2-negative Breast Cancer


Sponsor

Institute of Oncology Ljubljana

Enrollment

319 participants

Start Date

Jan 5, 2025

Study Type

OBSERVATIONAL

Conditions

Summary

Around 90% of breast cancer patients are diagnosed at an early stage and approximately 70% are hormone receptor-positive and HER2-negative (HR+/HER2-). Despite advancements in adjuvant endocrine therapy, 20-30% of early-stage breast cancer patients relapse within the first decade post-surgery. A recent clinically meaningful therapeutic option for these patients has been cyclin-dependent kinases 4/6 inhibitors (CDK4/6 inhibitors). Abemaciclib and ribociclib were assessed in the adjuvant setting, both showing improvement in invasive disease-free survival (IDFS). Abemaciclib has been approved by the FDA and EMA for HR+/HER2- early breast cancer at high risk of disease recurrence and is the first addition to the Slovenian treatment regimen in routine clinical practice. Poor medication adherence can directly affect the effectiveness of treatment for early HR+/HER2- breast cancer. While adherence data in patients treated with aromatase inhibitors are available, the adherence rate in patients with early HR+/HER2- breast cancer taking abemaciclib remains unclear. In this study, investigators hypothesize that patients receiving abemaciclib in combination with aromatase inhibitors will have lower medication adherence and higher discontinuation rates compared to those receiving aromatase inhibitors alone. It is expected that patients with better quality of life, better cognitive functioning, and a more positive attitude toward their therapy will demonstrate higher medication adherence rates. Adherence may also be influenced by additional factors, such as age and prior treatments.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study is tracking how well women with early-stage hormone receptor-positive (HR+), HER2-negative breast cancer stick to their aromatase inhibitor medication (such as letrozole, anastrozole, or exemestane), with or without an additional drug called abemaciclib. The goal is to understand what factors affect medication adherence in real-world patients. **You may be eligible if...** - You are a woman with early-stage HR-positive, HER2-negative breast cancer - You have been on an aromatase inhibitor (with or without abemaciclib) for no longer than 18 months - You are receiving care at OIL (Oncology Institute of Ljubljana) - You have Slovenian health insurance and understand the Slovenian language **You may NOT be eligible if...** - You have metastatic (stage 4) breast cancer - You have previously taken an aromatase inhibitor for early breast cancer before this current treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.


Locations(1)

Institute of Oncology Ljubljana

Ljubljana, Slovenia

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06650423


Related Trials