Ignite Creation Date:
2024-05-06 @ 5:37 PM
Last Modification Date:
2024-10-26 @ 2:32 PM
Study NCT ID:
NCT05375461
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2022-05-16
First Post:
2022-05-11
Brief Title:
TQB3616 Capsules Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer in Clinical Trail
Sponsor:
Chia Tai Tianqing Pharmaceutical Group Co Ltd
Organization:
Chia Tai Tianqing Pharmaceutical Group Co Ltd
Study Overview
Official Title:
A Phase IIIrandomized Double-blind Paralle Multi-center Study to Evaluate the Efficacy and Safety of TQB3616 Capsules Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Participants with Hormone Receptor HR-positive Human Epidermal Growth Factor ReceptorEGFR 2-Negative Advanced Breast Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
RECRUITING
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 is a Phase III a randomized double-blind parallel multi-center trail to evaluate the efficacy and safety of TQB3616 capsules plus fulvestrant compared to placebo plus fulvestrant in participants with estrogen receptor-positive HER2-Negative Advanced Breast Cancer Approximately 287 women will be randomized to either TQB3616 plus fulvestrant or TQB3616-matching placebo plus fulvestrant Randomization will follow a 21 randomization ratiothe experimental is 191 the Placebo Comparator is 96
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