This study is a randomized, positive parallel controlled, multicentre phase III clinical trial to evaluate the efficacy and safety of TQB2450 combined with anlotinib versus paclitaxel for injection (albumin bound) in subjects with advanced triple negative breast cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
332
TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors.
a multi-target receptor tyrosine kinase inhibitor.
a anti-microtubule drug.
Progression free survival (PFS) evaluated by Independent Review Committee(IRC)
PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause, based on IRC.
Time frame: up to 96 weeks
Overall response rate (ORR)
Percentage of participants achieving complete response (CR) and partial response (PR).
Time frame: up to 96 weeks
Disease control rate(DCR)
Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).
Time frame: up to 96 weeks
Duration of Response (DOR)
DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment.
Time frame: up to 96 weeks
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The Fourth Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Chinese Academy of Medical Sciencesand Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Beijing Shijitan Hospital Affiliated to Capital Medical University
Beijing, Beijing Municipality, China
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, China
Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, China
The First Affilited Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Guangxi Medical University Affiliated Tumor Hospital
Nanning, Guangxi, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
...and 20 more locations