Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06650423
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-16
Brief Title:
Adherence to Aromatase Inhibitors Abemaciclib Treatment in Patients With Early-stage HER2-negative Breast Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
ONCO-ADHER Adherence to Treatment With a Aromatase Inhibitors With or Without Abemaciclib in Patients With Early-stage Endocrine-dependent HER-2-negative Breast Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ONCO-Adher
Brief Summary:
Around 90 of breast cancer patients are diagnosed at an early stage and approximately 70 are hormone receptor-positive and HER2-negative HRHER2- Despite advancements in adjuvant endocrine therapy 20-30 of early-stage BC patients relapse within the first decade post-surgery Recent clinically meaningful therapeutic option for these patients has been cyclin-dependent kinases 46 inhibitors CDK46 inhibitors Abemaciclib and ribociclib were assessed in the adjuvant setting both showing improvement in IDFS Abemaciclib has been approved by the FDA and EMA for HRHER2- early breast cancer at high risk of disease recurrence and is the first addition to Slovenian treatment regimen in routine clinical practice Poor medication adherence can directly affect the effectiveness of treatment for early HRHER2- breast cancer While adherence data in patients treated with aromatase inhibitors are available the adherence rate in patients with early HRHER2- breast cancer taking abemaciclib is unclear In this study investigators hypothesize that patients receiving abemaciclib in combination with aromatase inhibitors will have a lower medication adherence and higher discontinuation rate compared to those receiving aromatase inhibitors alone It is expected that patient with better quality of life cognitive functioning and more positive attitude towards their therapy will demonstrate higher medication adherence rate Adherence rate will also be affected by other factors such as age and prior treatments
Detailed Description:
Breast cancer BC is the most prevalent malignant tumour in women with an estimated 2308 million new cases and over 665000 deaths globally in 2022 Around 90 of patients are diagnosed at an early stage and the majority of these cases approximately 70 are hormone receptor-positive and HER2-negative HRHER2- Despite advancements in adjuvant endocrine therapy that significantly lower recurrence and mortality rates 20-30 of early-stage BC patients experience relapse within the first decade post-surgery Around 12 of patients with HRHER2- BC belong to high-risk population with 5-years invasive disease-free survival IDFS of 702 vs 900 in non-high-risk The most recent clinically meaningful therapeutic option for these patients has been cyclin-dependent kinases 46 inhibitors CDK46 inhibitors Endocrine therapy combined with CDK46 inhibitors abemaciclib palbociclib and ribociclib is now the standard most effective and recommended treatment for these patients in the first or subsequent lines of treatment for advanced disease Two CDK46 inhibitors abemaciclib and ribociclib have been assessed also for use in the adjuvant setting MonarchE and NATALEE study Both studies showed improvement in IDFS of combined endocrine therapy and CDK46 inhibitor vs endocrine therapy alone Abemaciclib has been approved by both the FDA and EMA for patients with HRHER2- early breast cancer at high risk of disease recurrence and has therefore recently been added to Slovenian current regimen for this indication in routine clinical practice Non-adherence to adjuvant therapy may compromise the efficacy of combined treatment in preventing disease recurrence and mortality Some historical data report that only 60-70 of patients with early BC adhere to adjuvant therapy making adherence a significant challenge Key factors influencing adherence to cancer treatment include the perceived benefits of the treatment the setting in which the treatment is administered at home or in a hospital the associated risks the impact on quality of life and the costs involved Non-adherence often arises because patients do not experience the immediate benefits With no visible or measurable signs of the disease and no physical symptoms of the disease as is the case in patients receiving adjuvant treatment and given that many would not have experienced a relapse even without adjuvant therapy patients are much more likely to discontinue treatment if they experience adverse eventsreactions AE Adherence to treatment with CDK46 inhibitors in combination with aromatase inhibitors differs from some other systemic treatments due to the continuous treatment regimen that lasts for several years without interruption In early BC it lasts two abemaciclib or three ribociclib years and is associated with some specific AEs Aromatase inhibitors are associated with arthralgias myalgias and joint stiffness whereas CDK46 inhibitors with myelotoxicity hepatotoxicity and gastrointestinal symptoms especially diarrhoea caused by abemaciclib The duration of treatment five or more vs two years aromatase inhibitors as monotherapy vs abemaciclib in combination with aromatase inhibitors respectively may lead to different discontinuation rates Despite the growing amount of real-world experiences with combined treatment with aromatase inhibitors and abemaciclib in the adjuvant setting there is currently a lack of literature specifically exploring how patient adherence and attitudes are influenced by this combination This gap underscores the need for further research to fully understand the impact of these therapies on medication adherence Poor medication adherence can directly affect the effectiveness of treatment for early HRHER2- breast cancer While data on medication adherence in patients taking aromatase inhibitors are available the adherence rate in patients with early HRHER2- 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 a lower medication adherence and higher discontinuation rate compared to those receiving aromatase inhibitors alone Its also expected that patient with better quality of life better cognitive functioning and more positive attitude towards their therapy will demonstrate higher medication adherence rate Additionally its anticipated that other factors such as age and prior treatments will also contribute to adherence rates
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None