Treatment Efficacy Clinical Trial
Official title:
Combination of HX008 And Niraparib in GErm-line-mutAted Metastatic Breast Cancer: a muLti-centEr Phase II Study
A number of anti-PD-1/L1 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., Ltd.China) combined gemcitabine and cisplatin (GP) regimen for first-line treatment of advanced triple negative breast cancer has been shown good efficacy. On the other hand,HRD 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 repair(DDR), 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 and/or 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 (BRCA1/2, PALB2, CHEK2, ATM, ATR, BAP1, BARD1, BLM, BRIP1, CHEK1, CDK12, FANCA, FANCC, FANCD2, FANCE, FANCF, FANCM, MRE11A, NBN, PTEN, RAD50, RAD51C, RAD51D, WRN) pathogenic/suspected pathogenic germline mutation, so as to explore the possibility of more combined therapy for breast cancer to achieve better therapeutic effect.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05087381 -
Randomized-controlled Trial of the Effectiveness of COVID-19 Early Treatment in Community
|
Phase 4 | |
| Active, not recruiting |
NCT02551523 -
Early Simplified: A Trial to Compare the Efficacy of Standard of Care Combination Antiretroviral Therapy With a Simplified Dolutegravir Monotherapy in Patients With a Primary HIV-1 Infection
|
Phase 2 | |
| Recruiting |
NCT06221722 -
Predicting Treatment Outcomes in Refractory Constipation Through Brain Connectivity Evaluation
|
||
| Terminated |
NCT03503968 -
TCR Modified T Cells MDG1011 in High Risk Myeloid and Lymphoid Neoplasms
|
Phase 1/Phase 2 | |
| Completed |
NCT02572947 -
A Pilot Study of MONOtherapy of DOlutegravir in HIV-1 Virologically Suppressed Patients
|
Phase 2 | |
| Completed |
NCT05144295 -
Lubiprostone for Functional Constipation in the Under 18 Years Patients
|
Phase 3 | |
| Recruiting |
NCT05813951 -
Efficacy and Safety of Continuous Versus Intermittent Linezolid Infusion in Critically Ill Patients With Septic Shock
|
N/A | |
| Completed |
NCT03345160 -
Peanut Oral Immunotherapy in Children: IMPACT Follow Up Study
|
Phase 2 |