Ignite Creation Date:
2024-05-06 @ 3:03 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04508803
Status:
COMPLETED
Last Update Posted:
2022-06-30
First Post:
2020-08-09
Brief Title:
Combination of HX008 And Niraparib in GErm-line-mutAted Metastatic Breast Cancer
Sponsor:
Fudan University
Organization:
Fudan University
Study Overview
Official Title:
Combination of HX008 And Niraparib in GErm-line-mutAted Metastatic Breast Cancer a muLti-centEr Phase II Study
Status:
COMPLETED
Status Verified Date:
2020-06
Last Known Status:
RECRUITING
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:
CHANGEABLE
Brief Summary:
A number of anti-PD-1L1 monoclonal antibodies have been approved for the treatment of various advanced tumors in the world and many studies on anti-PD-1 L1 monoclonal antibodies for breast cancer are also being carried out HX008 Taizhou Hanzhong Biomedical Co LtdChina combined gemcitabine and cisplatin GP regimen for first-line treatment of advanced triple negative breast cancer has been shown good efficacy On the other handHRD as the target of PARP inhibitor therapy in the treatment of breast cancer has a broad prospect In HRD tumor patients the use of PARPi can make obstacles of DNA damage repairDDR accumulation of DNA damage thus promote the apoptosis of tumor cells Several PARPi have been approved worldwide including Olaparib Rucaparib Niraparib Talazoparib Veliparib for the treatment of ovarian andor breast cancer Theoretically PARPi and anti-PD-1 monoclonal antibody can play a synergistic mechanism In this study HX008 combined with Niraparib is designed to treat metastatic breast cancer patients with DDR gene BRCA12 PALB2 CHEK2 ATM ATR BAP1 BARD1 BLM BRIP1 CHEK1 CDK12 FANCA FANCC FANCD2 FANCE FANCF FANCM MRE11A NBN PTEN RAD50 RAD51C RAD51D WRN pathogenicsuspected pathogenic germline mutation so as to explore the possibility of more combined therapy for breast cancer to achieve better therapeutic effect
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