Ignite Creation Date:
2024-05-06 @ 1:49 PM
Last Modification Date:
2024-10-26 @ 1:20 PM
Study NCT ID:
NCT04133207
Status:
COMPLETED
Last Update Posted:
2021-02-12
First Post:
2019-10-15
Brief Title:
Clinical Outcome and Toxicity Data in Patients With Advanced Breast Cancer Treated With CDK Inhibitors Combined With Endocrine Therapy
Sponsor:
Hellenic Cooperative Oncology Group
Organization:
Hellenic Cooperative Oncology Group
Study Overview
Official Title:
Registry Study of Patients With Advanced Breast Cancer Treated With Cyclin-dependent Kinase 46 CDK46 Inhibitors Combined With Endocrine Therapy the Experience of the Hellenic Cooperative Oncology Group
Status:
COMPLETED
Status Verified Date:
2019-10
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:
HeCOGCDKi
Brief Summary:
The present study will assess real-world clinical outcomes and adverse events from treatment with endocrine therapy combined with CDKi in patients with HR-positive HER2-negative advanced breast cancer
Detailed Description:
Patients This will be a retrospective analysis of patients with histologically confirmed HR-positive HER2-negative advanced recurrent or metastatic breast cancer The investigators will use data from patients treated at Hellenic Cooperative Oncology Group HeCOG-affiliated departments of oncology Eligible patients will be of 18 years or older women of any menopausal status with HR-positiveHER2-negative advanced breast cancer who have received treatment with CDKi in combination with endocrine therapy for their advanced breast cancer Treatment combinations of CDKi with any endocrine therapy will be accepted Patients will be included in the analysis if they heve received at least two months of treatment with a CDKi Patient clinical data will be obtained from their medical records Toxicity data will be recorded from the clinicians documentations during scheduled patient clinical visits
Statistical analysis The primary endpoint of the study will be progression-free survival PFS defined as the time from treatment initiation to either the first documented disease progression or death from any cause Secondary endpoint will be overall survival OS defined as the time from treatment initiation to patient death or last contact Patients alive will be censored at the date of last contact Adverse events will be graded based on Common Terminology Criteria for Adverse Events CTCAE version 40 Survival curves will be estimated using the Kaplan-Meier method and compared across groups with the log-rank test The associations between the clinicopathological factors to be examined and the mortality rate will be evaluated with hazard ratios estimated with Cox proportional hazards model The statistical analyses will be completed using the SAS software SAS for Windows version 93 SAS Institute Inc Cary NC
Statistical analysis The primary endpoint of the study will be progression-free survival PFS defined as the time from treatment initiation to either the first documented disease progression or death from any cause Secondary endpoint will be overall survival OS defined as the time from treatment initiation to patient death or last contact Patients alive will be censored at the date of last contact Adverse events will be graded based on Common Terminology Criteria for Adverse Events CTCAE version 40 Survival curves will be estimated using the Kaplan-Meier method and compared across groups with the log-rank test The associations between the clinicopathological factors to be examined and the mortality rate will be evaluated with hazard ratios estimated with Cox proportional hazards model The statistical analyses will be completed using the SAS software SAS for Windows version 93 SAS Institute Inc Cary NC
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None