Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06338644
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-29
First Post:
2024-03-24
Brief Title:
Palbociclib in Metastatic Breast Cancer Gene Polymorphism-based Study in Egyptian Patients
Sponsor:
Helwan University
Organization:
Helwan University
Study Overview
Official Title:
Palbociclib in Metastatic Breast Cancer Gene Polymorphism-based Study in Egyptian Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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:
Palbociclib
Brief Summary:
Cyclin-dependent kinase CDK 46 inhibitors are a class of agents recently introduced in the clinic for the treatment of advanced hormone receptor-positive HR and HER2-negative HER2- BC Palbociclib ribociclib and abemaciclib have all been approved by the US Food and Drug Administration FDA and the European Medicines Agency among other regulatory bodies
Detailed Description:
Several factors are thought to influence the variability of treatment efficacy and toxicity including organ function comedications hormonal status body weight age comorbidities etc Among them single nucleotide polymorphisms SNPs as rs1128503 rs2032583 are attracting huge interest to address the interindividual variability in drug response whether in terms of efficacy or safety
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