Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06341283
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-10
First Post:
2024-03-26
Brief Title:
A Retrospective Real-world Study of Abemaciclib in HR Breast Cancer
Sponsor:
The Affiliated Hospital of Qingdao University
Organization:
The Affiliated Hospital of Qingdao University
Study Overview
Official Title:
A Retrospective Real-world Study of Efficacy Safety and Economic Assessment of Abemaciclib Tablets Based on Hospital Information SystemHIS in Hormone Recepter PositiveHR Breast Cancer Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
The present study will assess real-world clinical outcomes adverse events and economics from treatment with endocrine therapyET combined with abemaciclib in patients with hormone receptor-positiveHR breast cancer
Detailed Description:
Based on clinical trials data Abemaciclib has been approved for early and advanced breast cancer with HR and human epidermal growth factor 2 receptor-negativeHER2- but clinical trials require real-world research data as supplementary validation supporting evidence This study will assess real-world clinical outcomes adverse events and economics from treatment with endocrine therapyET combined with abemaciclib in patients with HR breast cancer In addition this trial will explore the efficacy of Abemaciclib in patients with HR and human epidermal growth factor 2 receptor-positiveHer2 breast cancer
This study will now include real-world data on efficacy toxicity and economics of abemaciclib in the adjuvant setting in HR breast cancer Participants to be enrolled will come from an online platform for researches which all the privacy information has been controlled The investigators are going to gather 2 groups of breast-cancer-one-other-studyBCOOS including BCOOS-A and BCOOS-B Group BCOOS-A includes the patients treated with Abemaciclib and LetrozoleAnastrozole compared with treated with LetrozoleAnastrozole only Group BCOOS-B includes the patients treated with Abemaciclib and Fulvestrant compared with treated with Fulvestrant only
Investigators will measure clinical outcomes adverse events and economics in each group above
This study will now include real-world data on efficacy toxicity and economics of abemaciclib in the adjuvant setting in HR breast cancer Participants to be enrolled will come from an online platform for researches which all the privacy information has been controlled The investigators are going to gather 2 groups of breast-cancer-one-other-studyBCOOS including BCOOS-A and BCOOS-B Group BCOOS-A includes the patients treated with Abemaciclib and LetrozoleAnastrozole compared with treated with LetrozoleAnastrozole only Group BCOOS-B includes the patients treated with Abemaciclib and Fulvestrant compared with treated with Fulvestrant only
Investigators will measure clinical outcomes adverse events and economics in each group above
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