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

Status: Recruiting
Location: See location...
Study Type: Observational
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Slovenia
Institute of Oncology Ljubljana
RECRUITING
Ljubljana
Contact Information
Primary
Erika Matos, PhD
ematos@onko-i.si
00386 1 5879 715
Backup
Cvetka Grašič Kuhar, PhD
cgrasic@onko-i.si
00386 1 5879 090
Time Frame
Start Date: 2025-01-05
Estimated Completion Date: 2027-03-01
Participants
Target number of participants: 319
Treatments
Aromatase inhibitor + abemaciclib
Adult women with early HR+ HER2- breast cancer, eligible for treatment with aromatase inhibitor + abemaciclib, both prescribed prior inclusion into study, irrespective of protocol, as per regular clinical practice
Aromatase inhibitor
Adult women with early HR+ HER2- breast cancer, eligible for treatment with aromatase inhibitor, prescribed prior inclusion into study, irrespective of protocol, as per regular clinical practice
Related Therapeutic Areas
Sponsors
Leads: Institute of Oncology Ljubljana
Collaborators: University of Ljubljana

This content was sourced from clinicaltrials.gov