Ignite Creation Date:
2024-05-06 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 2:32 PM
Study NCT ID:
NCT05365178
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-12-29
First Post:
2022-04-26
Brief Title:
To Evaluate the Efficacy and Safety of TQB3616 in Combination With Fulvestrant Versus Placebo in Combination With Fulvestrant in Previously Untreated Hormone-receptor HR-Positive Human Epidermal Growth Factor Receptor 2 HER2-Negative Advanced Breast Cancer
Sponsor:
Chia Tai Tianqing Pharmaceutical Group Co Ltd
Organization:
Chia Tai Tianqing Pharmaceutical Group Co Ltd
Study Overview
Official Title:
A Randomized Double-blind Parallel-controlled Phase III Trial Evaluating the Efficacy and Safety of TQB3616 in Combination With Fulvestrant Versus Placebo in Combination With Fulvestrant in Previously Untreated HR-positive HER2-negative Advanced Breast Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-12
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:
A randomized double-blind parallel-controlled multicenter trial design was used in this study Subjects who meet the criteria will be randomly divided into 21 groups to receive TBQ3616 capsule combined with Fulvestrant injection experimental group or placebo capsule combined with fulvestrant control group A total of 428 subjects were required
Detailed Description:
None
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