This is a phase II, explorative, open-labeled, multi-centered, double-arm, investigator-initiated clinical trial of Camrelizumab (an anti-PD-1 antibody) in combination with Nab-paclitaxel (a chemotherapeutic agent against breast cancer) and Levocetirizine (an antihistamine) in patients with advanced triple-negative breast cancer. 60 subjects will be enrolled in multiple centers. This study aims to evaluate the effects of Camrelizumab combined with Nab-paclitaxel and Levocetirizine in the treatment of advanced TNBC.
This is a phase II, explorative, open-labeled, multi-centered, double-arm, investigator-initiated clinical trial to evaluate the effects of Camrelizumab combined with Nab-paclitaxel and Levocetirizine in the treatment of advanced TNBC. The study aims to enroll 60 subjects in multiple centers. The primary objective is to assess the overall response rate (ORR). All enrolled patients will be treated with Camrelizumab 200mg (iv. 3mg/kg for patient whose weight is below 50kg) on day 1 of each 3 week, and Nab-paclitaxel 100mg/m2, iv, on d1,8,15 of each 4 week, in combination with Levocetirizine of 5mg, po., 3 days before 1st administration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Camrelizumab 200mg (3mg/kg for patient whose weight is below 50kg) will be administered as an intravenous infusion over 30 minutes every three weeks until unacceptable toxic effects or disease progression or other termination criteria appeared.
Nab paclitaxel 100mg/m2 will be administered as an intravenous infusion every 4 weeks in d1,8,15until unacceptable toxic effects or disease progression or other termination criteria appeared.
5mg daily, start 3 days before the 1st administration
Overall response rate (ORR)
The propotion of subjects with CR or PR.
Time frame: from the first drug administration up to the first occurrence of progression or death (up to 36 weeks)
Adverse events/Serious adverse events
Adverse events/Serious adverse events
Time frame: from the first drug administration to within 90 days for the last dose
Disease Control Rate (DCR)
The propotion of subjects with CR, PR, or SD.
Time frame: from the first drug administration up to the first occurrence of progression or death (up to 36 weeks)
Clinical benefit rate (CBR)
The propotion of subjects with CR, PR, or SD for \>=6 months during the study
Time frame: propotion of subjects with CR, PR, or SD for >=6 months (up to 36 weeks)
Duration of response (DoR)
The time from randomization to disease progression or death for patients who achieve complete or partial alleviation
Time frame: from the first drug administration up to the first occurrence of progression or death (up to 36 weeks)
Time to response (TTR)
Time from date of first dose to date of first occurrence of response
Time frame: from the first drug administration up to the first occurrence of progression (up to 36 weeks)
Progression-Free-Survival (PFS)
from the first drug administration up to the first occurrence of progression or death (up to 24 months)
Time frame: from the first drug administration up to the first occurrence of progression or death (up to 36 weeks)
Overall survival (OS)
12 months after the first drug administration
Time frame: 12 months after the first drug administration
Biomarkers
Compare the change of biomarkers from urine, blood or tissues, such as the carcinoembryonic antigen (ug/L), before or after the treatments.
Time frame: pre-treatment, up to 24 months
Biomarkers
Compare the change of biomarkers from urine, blood or tissues, such as the CA125/199/153(u/ml), before or after the treatments.
Time frame: pre-treatment, up to 24 months
patient reported outcomes (PRO)
direct reports from patients about their health, the scale Quality of Life questionnaire (QLQ)-BR23/C30 will be used for assecessment. Higher score indicate better life quality
Time frame: during the study and up to 36 weeks after the end
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.