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

Recruitingn/aAges 18 Years - 99 YearsFemaleInstitute of Oncology Ljubljana
NCT06650423 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 adher

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📋 Eligibility rules (as published)
Inclusion Criteria: * Female, * Early HR+/HER-2- BC, * Patient is receiving adjuvant therapy with an aromatase inhibitor (letrozole, anastrozole or exemestane), with or without a CDK4/6 inhibitor abemaciclib, for no more than 18 months, * Treatment of BC is being conducted at OIL, * Patient has mandatory health insurance through Health Insurance Institute of Slovenia, * Patient understands Slovenian language, and * Patient agrees to participate in the study and provides written informed consent. Exclusion Criteria: * Metastatic HR+/HER2-negative breast cancer * Previous treatment for breast cancer with an aromatase inhibitor, with or without a CDK4/6 inhibitor, for early breast cancer prior to the current adjuvant treatment line
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What it tests

  • Not listed
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Where

1 site
Institute of Oncology Ljubljana
Ljubljana, Slovenia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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