NCT06650423 Adherence to Aromatase Inhibitors ± Abemaciclib Treatment in Patients With Early-stage HER2-negative Breast Cancer
| NCT ID | NCT06650423 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institute of Oncology Ljubljana |
| Condition | Early Breast Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 319 participants |
| Start Date | 2025-01-05 |
| Primary Completion | 2027-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 319 participants in total. It began in 2025-01-05 with a primary completion date of 2027-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Erika Matos, PhD
PRINCIPAL INVESTIGATOR
Institute of Oncology Ljubljana, Slovenia
Frequently Asked Questions
Who can join the NCT06650423 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 99 Years, studying Early Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06650423 currently recruiting?
Yes, NCT06650423 is actively recruiting participants. Contact the research team at ematos@onko-i.si for enrollment information.
Where is the NCT06650423 trial being conducted?
This trial is being conducted at Ljubljana, Slovenia.
Who is sponsoring the NCT06650423 clinical trial?
NCT06650423 is sponsored by Institute of Oncology Ljubljana. The principal investigator is Erika Matos, PhD at Institute of Oncology Ljubljana, Slovenia. The trial plans to enroll 319 participants.
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