Ignite Creation Date:
2024-05-06 @ 5:47 PM
Last Modification Date:
2024-10-26 @ 2:36 PM
Study NCT ID:
NCT05439499
Status:
RECRUITING
Last Update Posted:
2022-07-06
First Post:
2022-06-24
Brief Title:
This is a Multicenter Randomized Double-blind Placebo-controlled Phase III Clinical Study Evaluating the Efficacy and Safety of FCN-437c Versus Placebo in Combination With Letrozole or Anastrozole Goserelin in Women With HR and HER2- Advanced Breast Cancer
Sponsor:
Ahon Pharmaceutical Co Ltd
Organization:
Ahon Pharmaceutical Co Ltd
Study Overview
Official Title:
A Multicenter Randomized Double-blind Placebo-controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of FCN-437c Versus Placebo in Combination With Letrozole or Anastrozole Goserelin in Women With HR-positive and HER2-negative Advanced Breast Cancer
Status:
RECRUITING
Status Verified Date:
2022-06
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 is a multicenter randomized double-blind placebo-controlled Phase III clinical study evaluating the efficacy and safety of FCN-437c in combination with letrozole or anastrozole Goserelin versus placebo combined with letrozole or anastrozole Goserelin in women with first-line advanced breast cancer in HR and HER2-
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