ONCO-ADHER: Adherence to Treatment With Aromatase Inhibitors With or Without Abemaciclib in Patients With Early-stage, Endocrine-dependent, HER2-negative Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 319
- 试验地点
- 1
- 主要终点
- Medication adherence (Proportion of Days Covered, PDC) at Month 3
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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
结局指标
主要结局
Medication adherence (Proportion of Days Covered, PDC) at Month 3
时间窗: 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
时间窗: 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).
次要结局
- EORTC QLQ-C30 score at Baseline(Baseline visit)
- EORTC QLQ-C30 score at Month 3(Month 3)
- EORTC QLQ-C30 score at Month 6(Month 6)
- EORTC QLQ-BR23 score at Baseline(Baseline visit)
- EORTC QLQ-BR23 score at Month 3(Month 3)
- EORTC QLQ-BR23 score at Month 6(Month 6)
- Beliefs about Medicines Questionnaire (BMQ) score at Baseline(Baseline visit)
- Beliefs about Medicines Questionnaire (BMQ) score at Month 3(Month 3)
- Beliefs about Medicines Questionnaire (BMQ) score at Month 6(Month 6)
- FACT-Cog score at Baseline(Baseline visit)
- FACT-Cog score at Month 3(Month 3)
- FACT-Cog score at Month 6(Month 6)
- Adverse events during follow-up(From treatment initiation through Month 6)
研究者
Erika Matos
assoc. prof. Erika Matos, MD, PhD
Institute of Oncology Ljubljana