Ignite Creation Date:
2024-05-06 @ 7:31 PM
Last Modification Date:
2024-10-26 @ 3:08 PM
Study NCT ID:
NCT06044623
Status:
RECRUITING
Last Update Posted:
2024-04-11
First Post:
2023-09-13
Brief Title:
Implementing Geriatric Assessment for Dose Optimization of Cyclin-dependent Kinase CDK 46-inhibitors in Older Breast Cancer Patients
Sponsor:
Region Örebro County
Organization:
Region Örebro County
Study Overview
Official Title:
Implementing Geriatric Assessment for Dose Optimization of CDK 46-inhibitors in Older Breast Cancer Patients - a Pragmatic Randomized-controlled Trial IMPORTANT Trial
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IMPORTANT
Brief Summary:
IMPORTANT study is a multicenter open-label prospective randomized-controlled non-inferiority trial with a pragmatic approach involving older patients 70 years old with advanced hormone receptor HR-positivehuman epidermal growth factor receptor 2 HER2-negative breast cancer not amenable for curative treatment and without prior therapy for advanced disease who are suitable to receive CDK 46-inhibitors plus endocrine therapy as first line therapy The study implements two approaches with high level of evidence namely the use of comprehensive geriatric assessment CGA approach in treatment decision making and the use of CDK 46-inhibitors as the initial treatment of choice to investigate whether a common clinical practice starting dose reduction of CDK 46-inhibitors in older patients with evidence of low certainty can be standardized using a more individualized-based approach
On the basis of baseline CGA assessment patients will either receive full dose of CDK 46-inhibitors plus endocrine therapy if patients are fit according to CGA or be randomized to full dose vs reduced initial dose of CDK 46-inhibitors if vulnerable or frail according to CGA The study hypothesis is that adjusting the dose according to vulnerability will allow patients to tolerate treatment better without jeopardizing the treatment efficacy
This project has received funding from the European Unions HORIZON 2022 research and innovation actions supporting the implementation of the Mission on Cancer under grant agreement No 101104589
On the basis of baseline CGA assessment patients will either receive full dose of CDK 46-inhibitors plus endocrine therapy if patients are fit according to CGA or be randomized to full dose vs reduced initial dose of CDK 46-inhibitors if vulnerable or frail according to CGA The study hypothesis is that adjusting the dose according to vulnerability will allow patients to tolerate treatment better without jeopardizing the treatment efficacy
This project has received funding from the European Unions HORIZON 2022 research and innovation actions supporting the implementation of the Mission on Cancer under grant agreement No 101104589
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None