Ignite Creation Date:
2024-05-06 @ 7:41 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06102824
Status:
RECRUITING
Last Update Posted:
2024-01-12
First Post:
2023-10-22
Brief Title:
Organoid-based Functional Precision Therapy for Advanced Breast Cancer
Sponsor:
Guangdong Provincial Peoples Hospital
Organization:
Guangdong Provincial Peoples Hospital
Study Overview
Official Title:
Organoid-Guided Functional Precision Therapy Versus Treatment of Physicians Choice in Previously Treated HER2-negative Advanced Breast Cancer a Phase II Multicenter Open-label Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-09
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:
ORIENTA
Brief Summary:
This is a phase II multicenter open-label randomized controlled trial to compare the efficacy of organoid-guided treatment OGT to treatment of physicians choice TPC in previously treated HER2-negative locally advanced or metastatic breast cancer The study will seek to provide evidence for utilizing patient-derived organoid PDO model to personalize treatment strategies and inform clinical care for advanced breast cancer Subjects randomized to the OGT group will undergo PDO generation and receive treatment dictated by subsequent PDO drug sensitivity screening Subjects randomized to the TPC group will receive empirical therapy as selected by the treating physician
Detailed Description:
Treatment for advanced-stage breast cancer has long been challenging Genomic-based precision medicine was able to facilitate treatment selection in some patients but there were considerable instances where genomic profiling failed to assign effective interventions or patients exhibited refractoriness to the drugs nominated by genomic alterations Patient-derived organoids PDOs represent a tractable tool that may compensate for the drawbacks of genomic medicine to identify therapeutic opportunities in rare or metastatic cancers Previous research has demonstrated that PDOs displayed strong biological fidelity to their original tumors and functional precision medicine based on PDO drug screening could confer survival benefits in breast cancer patients
This multicenter open-label randomized phase II trial aims to investigate the safety and efficacy of organoid-guided treatment OGT versus treatment of physicians choice TPC in previously treated HER2-negative locally advanced or metastatic breast cancer Randomization will be stratified by hormone receptor status and prior chemotherapy for the advanced or metastatic disease Subjects in the OGT group will receive treatment predicted to be the most efficacious by the PDO drug sensitivity screening and subjects in the TPC group will receive treatment selected by the treating physician Treatments tested in PDO drug screening or chosen by the treating physician will be guided by NCCN guidelines Treatment that subjects have previously received before randomization is no longer subjected to PDO sensitivity screening This study will provide valuable evidence on the real-time application of PDOs in the context of clinical care
This multicenter open-label randomized phase II trial aims to investigate the safety and efficacy of organoid-guided treatment OGT versus treatment of physicians choice TPC in previously treated HER2-negative locally advanced or metastatic breast cancer Randomization will be stratified by hormone receptor status and prior chemotherapy for the advanced or metastatic disease Subjects in the OGT group will receive treatment predicted to be the most efficacious by the PDO drug sensitivity screening and subjects in the TPC group will receive treatment selected by the treating physician Treatments tested in PDO drug screening or chosen by the treating physician will be guided by NCCN guidelines Treatment that subjects have previously received before randomization is no longer subjected to PDO sensitivity screening This study will provide valuable evidence on the real-time application of PDOs in the context of clinical care
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