Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06383767
Status:
RECRUITING
Last Update Posted:
2024-04-30
First Post:
2024-04-22
Brief Title:
A Phase III Study of ESG401 for Locally Advanced or Metastatic HRHER2- Breast Cancer
Sponsor:
Shanghai Escugen Biotechnology Co Ltd
Organization:
Shanghai Escugen Biotechnology Co Ltd
Study Overview
Official Title:
A Open-label Randomized Multicenter Phase III Study of ESG401 Versus Investigators Choice Chemotherapy in Patients With Locally Advanced or Metastatic HRHER2- Breast Cancer Who Had Failed at Least One Line of Chemotherapy
Status:
RECRUITING
Status Verified Date:
2024-04
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:
The aim of this study is to evaluate the efficacy and safety of ESG401 in patients with unresectable locally advanced or metastatic HRHER2- breast cancer
Detailed Description:
This is a open-label randomized multicenter Phase 3 study to evaluate ESG401 versus Treatment of Physicians Choice TPC in subjects with unresectable locally advanced or metastatic HRHER2- breast cancer who had failed at least one line of systemic chemotherapy
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