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| Name | Class |
|---|---|
| University of Ljubljana | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | Month 3 after treatment initiation |
| 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). | Month 6 after treatment initiation |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline visit |
| EORTC QLQ-C30 score at Month 3 |
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Inclusion Criteria:
Exclusion Criteria:
Adult women, sex at birth female
Eligible adult women with early HR+ HER2- breast cancer patients.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Erika Matos, PhD | Contact | 00386 1 5879 715 | ematos@onko-i.si | |
| Cvetka Grašič Kuhar, PhD | Contact | 00386 1 5879 090 | cgrasic@onko-i.si |
| Name | Affiliation | Role |
|---|---|---|
| Erika Matos, PhD | Institute of Oncology Ljubljana, Slovenia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Oncology Ljubljana | Recruiting | Ljubljana | 1000 | Slovenia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38572751 | Background | Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, Jemal A. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024 Apr 4. | |
| 36633525 | Background |
| Label | URL |
|---|---|
| SmPC abemaciclib | View source |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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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). |
| Month 3 |
| 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). | Month 6 |
| 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). | Baseline visit |
| EORTC QLQ-BR23 score at 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). | Month 3 |
| EORTC QLQ-BR23 score at 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). | Month 6 |
| Beliefs about Medicines Questionnaire (BMQ) score at Baseline | 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. | Baseline visit |
| Beliefs about Medicines Questionnaire (BMQ) score at 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. | Month 3 |
| Beliefs about Medicines Questionnaire (BMQ) score at 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. | Month 6 |
| FACT-Cog score at Baseline | 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). | Baseline visit |
| FACT-Cog score at 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). | Month 3 |
| FACT-Cog score at 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). | Month 6 |
| Adverse events during follow-up | 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. | From treatment initiation through Month 6 |
| Siegel RL, Miller KD, Wagle NS, Jemal A. Cancer statistics, 2023. CA Cancer J Clin. 2023 Jan;73(1):17-48. doi: 10.3322/caac.21763. |
| 36190501 | Background | Giaquinto AN, Sung H, Miller KD, Kramer JL, Newman LA, Minihan A, Jemal A, Siegel RL. Breast Cancer Statistics, 2022. CA Cancer J Clin. 2022 Nov;72(6):524-541. doi: 10.3322/caac.21754. Epub 2022 Oct 3. |
| 26211827 | Background | Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Aromatase inhibitors versus tamoxifen in early breast cancer: patient-level meta-analysis of the randomised trials. Lancet. 2015 Oct 3;386(10001):1341-1352. doi: 10.1016/S0140-6736(15)61074-1. Epub 2015 Jul 23. |
| 35611679 | Background | Sheffield KM, Peachey JR, Method M, Grimes BR, Brown J, Saverno K, Sugihara T, Cui ZL, Lee KT. A real-world US study of recurrence risks using combined clinicopathological features in HR-positive, HER2-negative early breast cancer. Future Oncol. 2022 Jul;18(21):2667-2682. doi: 10.2217/fon-2022-0310. Epub 2022 May 25. |
| 31859246 | Background | Gao JJ, Cheng J, Bloomquist E, Sanchez J, Wedam SB, Singh H, Amiri-Kordestani L, Ibrahim A, Sridhara R, Goldberg KB, Theoret MR, Kluetz PG, Blumenthal GM, Pazdur R, Beaver JA, Prowell TM. CDK4/6 inhibitor treatment for patients with hormone receptor-positive, HER2-negative, advanced or metastatic breast cancer: a US Food and Drug Administration pooled analysis. Lancet Oncol. 2020 Feb;21(2):250-260. doi: 10.1016/S1470-2045(19)30804-6. Epub 2019 Dec 16. |
| 32954927 | Background | Johnston SRD, Harbeck N, Hegg R, Toi M, Martin M, Shao ZM, Zhang QY, Martinez Rodriguez JL, Campone M, Hamilton E, Sohn J, Guarneri V, Okada M, Boyle F, Neven P, Cortes J, Huober J, Wardley A, Tolaney SM, Cicin I, Smith IC, Frenzel M, Headley D, Wei R, San Antonio B, Hulstijn M, Cox J, O'Shaughnessy J, Rastogi P; monarchE Committee Members and Investigators. Abemaciclib Combined With Endocrine Therapy for the Adjuvant Treatment of HR+, HER2-, Node-Positive, High-Risk, Early Breast Cancer (monarchE). J Clin Oncol. 2020 Dec 1;38(34):3987-3998. doi: 10.1200/JCO.20.02514. Epub 2020 Sep 20. |
| 38507751 | Background | Slamon D, Lipatov O, Nowecki Z, McAndrew N, Kukielka-Budny B, Stroyakovskiy D, Yardley DA, Huang CS, Fasching PA, Crown J, Bardia A, Chia S, Im SA, Ruiz-Borrego M, Loi S, Xu B, Hurvitz S, Barrios C, Untch M, Moroose R, Visco F, Afenjar K, Fresco R, Severin I, Ji Y, Ghaznawi F, Li Z, Zarate JP, Chakravartty A, Taran T, Hortobagyi G. Ribociclib plus Endocrine Therapy in Early Breast Cancer. N Engl J Med. 2024 Mar 21;390(12):1080-1091. doi: 10.1056/NEJMoa2305488. |
| 20803066 | Background | Hershman DL, Shao T, Kushi LH, Buono D, Tsai WY, Fehrenbacher L, Kwan M, Gomez SL, Neugut AI. Early discontinuation and non-adherence to adjuvant hormonal therapy are associated with increased mortality in women with breast cancer. Breast Cancer Res Treat. 2011 Apr;126(2):529-37. doi: 10.1007/s10549-010-1132-4. Epub 2010 Aug 28. |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |