Ignite Creation Date:
2024-05-06 @ 5:19 PM
Last Modification Date:
2024-10-26 @ 2:26 PM
Study NCT ID:
NCT05267327
Status:
NOT_YET_RECRUITING
Last Update Posted:
2022-03-04
First Post:
2022-02-28
Brief Title:
A Prospective Post-Marketing Observational Safety Study of Verzenios Abemaciclib Among Breast Cancer Patients in China Verzenios Abemaciclib Among Breast
Sponsor:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Organization:
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study Overview
Official Title:
A Prospective Post-Marketing Observational Safety Study of Verzenios Abemaciclib Among Breast Cancer Patients in China
Status:
NOT_YET_RECRUITING
Status Verified Date:
2022-02
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:
This PMSS is a single-country prospective observational study primarily designed to estimate the incidence of AEs and SAEs among Chinese patients with breast cancer after receiving Verzenios over a period of approximately 24 weeks in a routine clinical practice According to the pivotal studies MONARCH 2 3 and MONARCH plus the most frequent treatment-emergent adverse events TEAEs generally reported occurred at an early time within 28 days after treatment initiation point during treatment Dickler et al 2017 hence each patient enrolled in the study will have the first follow-up visit at 4 1 weeks after the first abemaciclib treatment for regular safety monitoring Since most reported TEAEs occur within 6 months patients will return to the clinic after receiving Verzenios for 6 months to carry out the routine effectiveness evaluation in the normal clinical practice setting The observational duration for primary objective is set as 24 4 weeks Moreover the effectiveness related variables including ORR DCR EFS rate and OS rate if available will be investigated as the secondary objectives of the study and patients will be followed for 24 4 weeks and up to 2 years only for EFS rate and OS rate after initiation of Verzenios Approximately 30 hospitals across China are planned for participation in this study This study plans to enroll approximately 1500 patients detailed in Section 95 and both safety and effectiveness of Verzenios will be evaluated The observation period for each patient will be either until the last Verzenios treatment if patients discontinue Verzenios before the follow-up duration of 24 weeks for safety and effectiveness EFS rate and OS rate will be assessed at 52 weeks and 104 weeks 30 days follow-up will be carried out for safety events or follow-up discontinuation for example death whichever comes first Visits will be performed at baseline baseline visit 4 weeks Visit 1 12 weeks Visit 2 and 24 weeks Visit 3 of treatment for safety and effectiveness assessments Follow-up visits will be performed at 52 weeks Visit 4 and 104 weeks Visit 5 of treatment for OS rate assessment
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?:
False
Is an FDA AA801 Violation?:
None