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.
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,
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
Eligible adult women with early HR+ HER2- breast cancer patients.
Cohort
Prospective
Not listed
Medication adherence (Proportion of Days Covered, PDC) at Month 3
Medication adherence measured as Proportion of Days Covered (PDC), calculated from pill count data and expressed as percentage (%). Participants with PDC ≥80% will be classified as adherent. Self-reported adherence will additionally be assessed using the Medication Adherence Report Scale (MARS-5; score range 5-25, higher scores indicate better adherence).
Medication adherence (Proportion of Days Covered, PDC) at Month 6
Medication adherence measured as Proportion of Days Covered (PDC), calculated from pill count data and expressed as percentage (%). Participants with PDC ≥80% will be classified as adherent. Self-reported adherence will additionally be assessed using the Medication Adherence Report Scale (MARS-5; score range 5-25, higher scores indicate better adherence).
EORTC QLQ-C30 score at Baseline
Quality of life assessed using the EORTC QLQ-C30 questionnaire. Scores are transformed to a 0-100 scale (higher scores on functional and global scales indicate better functioning; higher scores on symptom scales indicate greater symptom burden).
EORTC QLQ-C30 score at Month 3
Quality of life assessed using the EORTC QLQ-C30 questionnaire. Scores are transformed to a 0-100 scale (higher scores on functional and global scales indicate better functioning; higher scores on symptom scales indicate greater symptom burden).
EORTC QLQ-C30 score at Month 6
Quality of life assessed using the EORTC QLQ-C30 questionnaire. Scores are transformed to a 0-100 scale (higher scores on functional and global scales indicate better functioning; higher scores on symptom scales indicate greater symptom burden).
EORTC QLQ-BR23 score at Baseline
Quality of life assessed using the EORTC QLQ-BR23 questionnaire. Scores are transformed to a 0-100 scale (higher scores on functional scales indicate better functioning; higher scores on symptom scales indicate greater symptom burden).
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Institute of Oncology Ljubljana
Lead sponsor
University of Ljubljana
Collaborator
