This Phase II/III study assessed the efficacy, safety, pharmacokinetics, and immunogenicity of B013 administered with nab-paclitaxel in participants with locally advanced or metastatic triple negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic breast cancer (mBC).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
62
B013 at a fixed dose of 600 milligrams via intravenous (IV) infusion on Days 1 and 15 of the first 28-day cycle, then on Day 1 of each subsequent 28-day cycle. Nab-Paclitaxel 100 mg/m\^2 is administered weekly on Days 1, 8, 15 of each 28-day cycle.
Affiliated Cancer Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China
Hainan cancer Hospital
Haikou, Hainan, China
Objective response rate (ORR)(phase Ⅱ)
tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1.
Time frame: Baseline up to approximately 18 months
Progression-free survival (PFS)(IRC) (phase Ⅲ)
from the start date of study treatment to the date of progression disease or death , whichever occurred first.
Time frame: Baseline up to approximately 18 months
Disease control rate (DCR)
DCR was defined as the percentage of patients who have achieved complete response, partial response and stable disease
Time frame: 18 months
Duration of remission (DOR)
DOR was defined for participants who had an objective response as the time from the first occurrence of a documented unconfirmed response (CR or PR) to the date of disease progression per RECIST v1.1 or death from any cause
Time frame: 18 months
Time to Response (TTR)
Defined as the interval from the start of study therapy to the first documentation of an objective response
Time frame: 18 months
Overall Survival (OS)
Determination of the overall survival times of all patients
Time frame: 3years
Drug concentration in plasma
Determination of drug concentration in plasma of all patients
Time frame: 18 months
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The First Affiliated Hospital of henan University of Science and Technoloy
Luoyang, Henan, China
Xiangyang Central Hospital
Xiangyang, Hubei, China
The Central Hospital of Yongzhou
Yongzhou, Hunan, China
Huai'an First People's Hospital
Huai'an, Jiangsu, China
Sichuan Cancer Hospital
Chengdu, Sichuan, China
The second people's hospital of neijiang
Neijiang, Sichuan, China
Yunnan Cancer Hospital
Kunming, Yunnan, China
...and 3 more locations
Incidence of Treatment-Emergent Adverse Events
Adverse event type, incidence, duration, correlation with study drug
Time frame: 3years