Ignite Creation Date:
2024-05-06 @ 5:48 PM
Last Modification Date:
2024-10-26 @ 2:35 PM
Study NCT ID:
NCT05433480
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-07-27
First Post:
2022-06-16
Brief Title:
A Study of BPI-16350 in Combination With Fulvestrant in Patients With HR and HER2- Locally Advanced Recurrent or Metastatic Breast Cancer
Sponsor:
Betta Pharmaceuticals Co Ltd
Organization:
Betta Pharmaceuticals Co Ltd
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Phase 3 Study to Compare Fulvestrant Plus BPI-16350 or Plus Placebo in Patients With HR HER2- Locally Advanced Recurrent or Metastatic Breast Cancer With Disease Progression Following Endocrine Therapy
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-05
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:
This is a phase III clinical trial to evaluate the efficacy and safety of BPI-16350 in combination with Fulvestrant versus placebo combined with Fulvesrant in Patients who have HR positive and HER2 negative locally advancedrecurrent or metastatic breast cancer with disease progression following endocrine therapy
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