Ignite Creation Date:
2024-05-06 @ 8:08 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06268652
Status:
RECRUITING
Last Update Posted:
2024-02-20
First Post:
2024-01-23
Brief Title:
Patient Derived Organoid-guided Personalized Treatment Versus Treatment of Physicians Choice in Breast Cancer
Sponsor:
Sun Yat-sen University
Organization:
Sun Yat-sen University
Study Overview
Official Title:
Patient Derived Organoid-guided Personalized Treatment Versus Treatment of Physicians Choice in Patients With Relapsed and Refractory Breast Cancera Multicenter Randomized Controlled Phase III Trial
Status:
RECRUITING
Status Verified Date:
2024-02
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 multicenter open-label randomized phase III trial is designed to study the efficacy and safety of organoid-guided personalized treatment OGPTversus treatment of physicians choice TPC in previously treated refractory breast cancer
Detailed Description:
This multicenter open-label randomized phase III trial is designed to study the efficacy and safety of organoid-guided personalized treatment OGPTversus treatment of physicians choice TPC in previously treated refractory breast cancer Molecular subtype presence of visceral metastases and number of prior chemotherapy treatments for advanced or metastatic disease will stratify randomization subjects in the OGPT arm will receive the treatment predicted to be the most effective by PDO drug sensitivity screening and subjects in the TPC arm will receive treatment of physicians choice The primary population to be included in the study will be patients with refractory breast cancer who have received multiple lines of prior therapy and who have at least one measurable target lesion according to RECIST 11 criteria
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