Adherence to Aromatase Inhibitors ± Abemaciclib Treatment in Patients With Early-stage HER2-negative Breast Cancer
NCT ID: NCT06650423
Last Updated: 2024-10-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
319 participants
OBSERVATIONAL
2024-10-20
2026-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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
No interventions assigned to this group
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
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* Previous treatment for BC with an aromatase inhibitor, with or without a CDK4/6 inhibitor, due to BC.
18 Years
99 Years
FEMALE
No
Sponsors
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University of Ljubljana
OTHER
Erika Matos
OTHER
Responsible Party
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Erika Matos
assoc. prof. Erika Matos, MD, PhD
Principal Investigators
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Erika Matos, PhD
Role: PRINCIPAL_INVESTIGATOR
Institute of Oncology Ljubljana, Slovenia
Central Contacts
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References
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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.
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.
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.
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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.
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.
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.
Yussof I, Mohd Tahir NA, Hatah E, Mohamed Shah N. Factors influencing five-year adherence to adjuvant endocrine therapy in breast cancer patients: A systematic review. Breast. 2022 Apr;62:22-35. doi: 10.1016/j.breast.2022.01.012. Epub 2022 Jan 24.
Yeo HY, Liew AC, Chan SJ, Anwar M, Han CH, Marra CA. Understanding Patient Preferences Regarding the Important Determinants of Breast Cancer Treatment: A Narrative Scoping Review. Patient Prefer Adherence. 2023 Oct 31;17:2679-2706. doi: 10.2147/PPA.S432821. eCollection 2023.
Zhao M, Zhao J, Chen J, Li M, Zhang L, Luo X, Zhang Y, Xiong C, Guo Z, Yan J. The relationship between medication adherence and illness perception in breast cancer patients with adjuvant endocrine therapy: beliefs about medicines as mediators. Support Care Cancer. 2022 Dec;30(12):10009-10017. doi: 10.1007/s00520-022-07411-w. Epub 2022 Oct 20.
Agostinetto E, Vian L, Caparica R, Bruzzone M, Ceppi M, Lambertini M, Ponde N, de Azambuja E. CDK4/6 inhibitors as adjuvant treatment for hormone receptor-positive, HER2-negative early breast cancer: a systematic review and meta-analysis. ESMO Open. 2021 Apr;6(2):100091. doi: 10.1016/j.esmoop.2021.100091. Epub 2021 Mar 18.
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Giesinger JM, Kieffer JM, Fayers PM, Groenvold M, Petersen MA, Scott NW, Sprangers MA, Velikova G, Aaronson NK; EORTC Quality of Life Group. Replication and validation of higher order models demonstrated that a summary score for the EORTC QLQ-C30 is robust. J Clin Epidemiol. 2016 Jan;69:79-88. doi: 10.1016/j.jclinepi.2015.08.007. Epub 2015 Sep 28.
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Burnier M. Is There a Threshold for Medication Adherence? Lessons Learnt From Electronic Monitoring of Drug Adherence. Front Pharmacol. 2019 Jan 9;9:1540. doi: 10.3389/fphar.2018.01540. eCollection 2018.
Yang S, Park SW, Bae SJ, Ahn SG, Jeong J, Park K. Investigation of Factors Affecting Adherence to Adjuvant Hormone Therapy in Early-Stage Breast Cancer Patients: A Comprehensive Systematic Review. J Breast Cancer. 2023 Aug;26(4):309-333. doi: 10.4048/jbc.2023.26.e22. Epub 2023 May 10.
Related Links
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SmPC abemaciclib
U.S Food and Drug Administration. FDA expands early breast cancer indication for abemaciclib with endocrine therapy 2023
FACIT Group. FACT-Cog Scoring document
Fayers P, Bjordal K, Groenvold M, Curran D, Bottomley A. Brussels ORTC. Brussels: EORTC Brussels; 2001. EORTC QLQ-C30 Scoring Manual. 3rd ed.
Other Identifiers
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ORI2024-001
Identifier Type: -
Identifier Source: org_study_id
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