Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06519370
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-18
Brief Title:
FDA018-ADC Vs Investigators Choice Chemotherapy to Treat Locally Advanced Recurrent or Metastatic Triple-negative Breast Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 3 Open-label Randomised Study of FDA018-ADC Versus Investigators Choice of Chemotherapy in Patients Who Recurred During or After Taxane Therapy in Locally Advanced or Metastatic Triple-negative Breast Cancer
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase III randomized open-label 2-arm multicentre international study assessing the efficacy and safety of FDA018-ADC compared with Investigators Choice ChemotherapyICC in participants with locally recurrent inoperable or metastatic Triple-negative Breast CancerTNBC who are resistant to or recurring during or after taxane therapy
Detailed Description:
The primary objectives of the study are to demonstrate the superiority of FDA018-ADC relative to ICC by assessment of PFS per Blinded Independent Central ReviewBICR and OS in participants with locally recurrent inoperable or metastatic TNBC who are resistant to or recurring during or after taxane therapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None