Ignite Creation Date:
2024-07-17 @ 11:01 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06495164
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-07-03
Brief Title:
A Real-life Study to Understand the Use and Effects of Palbociclib in US Patients With Breast Cancer
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
Palbociclib Treatment Patterns and Outcomes in HRHER2- MBC Flatiron Database Analysis
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
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:
None
Brief Summary:
Palbociclib the first oral CDK46 inhibitor is an approved medicine indicated for the treatment of a kind of advancedmetastatic breast cancer MBC called hormone receptors positive HR Human epidermal growth factor receptor 2 negative HER2- disease Palbociclib is given orally in combination with hormonal therapies
The purpose of this study is to better understand how Palbociclib combination is used in real-life conditions and its clinical impact compared with hormonal therapy The study will also evaluate how long patients take the different CDK 46 inhibitor drugs and whether using those drugs impacts the use of chemotherapy later
Male and female patients aged 18 years old or more presenting the following conditions will be selected for the study
HRHER2- MBC
First treatment with Palbociclib hormonal therapy or other CDK46 inhibitors after MBC diagnosis The study will use data without personal identity which were obtained from medical records in routine clinical practice
The purpose of this study is to better understand how Palbociclib combination is used in real-life conditions and its clinical impact compared with hormonal therapy The study will also evaluate how long patients take the different CDK 46 inhibitor drugs and whether using those drugs impacts the use of chemotherapy later
Male and female patients aged 18 years old or more presenting the following conditions will be selected for the study
HRHER2- MBC
First treatment with Palbociclib hormonal therapy or other CDK46 inhibitors after MBC diagnosis The study will use data without personal identity which were obtained from medical records in routine clinical practice
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?:
None
Is an FDA AA801 Violation?:
None