Combination of HX008 And Niraparib in GErm-line-mutAted Metastatic Breast Cancer
Status:
Not yet recruiting
Trial end date:
2022-04-28
Target enrollment:
Participant gender:
Summary
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.