This is a phase II, open-labeled, multi-centered,single-arm, Investigator-initiated clinical trial of camrelizumab (an anti-PD-1 antibody) in combination with apatinib (a VEGFR2 TKI) and eribulin mesylate in patients with advanced triple-negative breast cancer. We will enroll 46 subjects (Simons two stage design). This study aims to evaluate the efficacy and safety of camrelizumab combined with apatinib and eribulin in the treatment of advanced TNBC.
This a phase II, open-labeled, multi-centered, single-arm, investigator-initiated clinical trial to assess the efficacy and safety of camrelizumab combination with apatinib and eribulin in female patients age of 18 to 70 with advanced TNBC, and previously treated with at least one line of systemic therapy in the advanced setting. Prior therapy (adjuvant/neoadjuvant/advanced) must have included an anthracycline and a taxane. The number of patients to be included is 46 patients (Simons two stage design). 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 21-day cycle, and apatinib 250mg daily (po, d1-d21), in combination with eribulin mesylate at 1.4 mg/m2 (iv.) on day 1 and day 8 of every 21-day cycle.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
46
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. Patients received up to two years of treatment.
Apatinib 250mg will be administered daily until unacceptable toxic effects or disease progression or other termination criteria appeared. Patients received up to two years of treatment.
Eribulin Mesylate will be administered as a 1.4 mg/m2 intravenous (IV) injection over 2 to 5 minutes on day 1 and day 8 of each 21-day cycle until unacceptable toxic effects or disease progression or other termination criteria appeared. Patients received up to two years of treatment.
The First Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China
Changhai Hospital, Navy Medical University (Second Military Medical University)
Shanghai, Shanghai Municipality, China
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 24 months)
Incidence of Treatment-Emergent 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 24 months)
DOR
Duration of response
Time frame: from the first drug administration up to the first occurrence of progression or death(up to 24 months)
PFS
Progression-Free-Survival
Time frame: from the first drug administration up to the first occurrence of progression or death (up to 24 months)
One year-OS rate
One year-Overall survival rate
Time frame: 12 months after the first drug administration
Clinical benefit rate (CBR)
The propotion of subjects with CR, PR, or SD for \>=6 months during the study.
Time frame: from the first drug administration up to the first occurrence of progression or death(up to 24 months)
TTR
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Time to response
Time frame: from the first drug administration up to one year
Frequencies of Biomarkers
Biomarkers (including tumor/stromal PD-L1, stromal PD-1, tumor-infiltrating lymphocytes and tumor-infiltrating B cells, eg)
Time frame: pre-treatment, up to 24 months