This trial used a multicentre, single-arm design in which patients were treated with AK105 plus Anlotinib Hydrochloride combined with albumin paclitaxel. Patients included in this trial were advanced breast cancer with hormone receptor negative and Her2 negative. The primary endpoint is ORR, and the secondary endpoint is DCR, PFS, OS and safety.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
42
AK105: 100mg per bottle, 200mg IV Day 1, cycled every 21 days
Anlotinib Hydrochloride: 12mg per capsule, 12 mg PO once daily on Days 1-14, cycled every 21 days
Albumin paclitaxel: 100mg per bottle, 125mg/m2 IV Days 1, 8, cycled every 21 days
Overall Response Rate (ORR)
Overall response rate (ORR) is defined as the proportion of patients with the best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1.
Time frame: Up to approximately 10 months
Disease Control Rate (DCR)
DCR: Disease Control Rate, defined as the proportion of patients with the best overall response of complete response (CR) , partial response (PR) or stable disease (SD) according to RECIST 1.1.
Time frame: Up to approximately 10 months
Progression Free Survival (PFS)
PFS is defined as the time from the date of randomization to the date of the first documented progression or death due to any cause.
Time frame: Up to approximately 10 months
Overall Survival (OS)
OS: Time from date of randomization to the date of death from any cause.
Time frame: Up to approximately 18 months
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