Early Breast Cancer, HER2-negative Breast Cancer, Hormone Receptor Positive Tumor
Conditions
Keywords
breast cancer, medication adherence, CDK4/6, HR+, HER2-, aromatase inhibitor, quality of life, medication belief
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.
Detailed description
Poor medication adherence can directly affect the effectiveness of treatment for early HR+/HER2- breast cancer. While data on medication adherence in patients taking aromatase inhibitors are available, the adherence rate in patients with early HR+/HER2- breast cancer taking abemaciclib remains unclear. Due to the differing characteristics of these treatment modalities, particularly their distinct safety profiles, medication adherence and persistence may vary between them. It is hypothesized 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 also 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. Additionally, factors such as age and prior treatments may contribute to adherence outcomes.
Interventions
None listed
Sponsors
Institute of Oncology Ljubljana
University of Ljubljana
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medication adherence (Proportion of Days Covered, PDC) at Month 3 | Month 3 after treatment initiation | 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 | Month 6 after treatment initiation | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EORTC QLQ-C30 score at Baseline | Baseline visit | 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 | 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 | 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 | Baseline visit | 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). |
| EORTC QLQ-BR23 score at Month 3 | Month 3 | 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). |
| EORTC QLQ-BR23 score at Month 6 | Month 6 | 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). |
| Beliefs about Medicines Questionnaire (BMQ) score at Baseline | Baseline visit | Beliefs about medicines assessed using the Beliefs about Medicines Questionnaire (BMQ). Items are rated on a 5-point Likert scale and summed to generate questionnaire scores. |
| Beliefs about Medicines Questionnaire (BMQ) score at Month 3 | Month 3 | Beliefs about medicines assessed using the Beliefs about Medicines Questionnaire (BMQ). Items are rated on a 5-point Likert scale and summed to generate questionnaire scores. |
| Beliefs about Medicines Questionnaire (BMQ) score at Month 6 | Month 6 | Beliefs about medicines assessed using the Beliefs about Medicines Questionnaire (BMQ). Items are rated on a 5-point Likert scale and summed to generate questionnaire scores. |
| FACT-Cog score at Baseline | Baseline visit | Cognitive functioning assessed using the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) questionnaire. Items are rated on a 0-4 scale and summed to generate domain and total scores (higher scores indicate better perceived cognitive functioning). |
| FACT-Cog score at Month 3 | Month 3 | Cognitive functioning assessed using the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) questionnaire. Items are rated on a 0-4 scale and summed to generate domain and total scores (higher scores indicate better perceived cognitive functioning). |
| FACT-Cog score at Month 6 | Month 6 | Cognitive functioning assessed using the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) questionnaire. Items are rated on a 0-4 scale and summed to generate domain and total scores (higher scores indicate better perceived cognitive functioning). |
| Adverse events during follow-up | From treatment initiation through Month 6 | Number of participants experiencing at least one adverse event and total number of adverse events recorded during follow-up. Adverse events will be summarized by severity and seriousness. |
Countries
Slovenia
Contacts
CONTACTErika Matos, PhD
CONTACTCvetka Grašič Kuhar, PhD
PRINCIPAL_INVESTIGATORErika Matos, PhD
Institute of Oncology Ljubljana, Slovenia
Outcome results
None listed