To evaluate the efficacy,safety and immunogenicity of TQ-B211 plus docetaxel versus Herceptin® plus docetaxel in Patients with HER2-positive metastatic breast cancer.Trastuzumab plus docetaxel was chosen as the comparator in the control group,as it represents a common first-line treatment option used in HER2+ MBC population in China.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
338
Participants will receive TQ-B211 8 milligrams/kilogram (mg/kg) intravenously(iv.) on day 1 in Cycle 1 followed by 6 mg/kg iv.on day 1 in Cycles 2 to 8.
Participants will receive Herceptin® 8 milligrams/kilogram (mg/kg) intravenously(iv.) on day 1 in Cycle 1 followed by 6 mg/kg iv.on day 1 in Cycles 2 to 8.
Participants will receive docetaxel 75 milligrams/square meter (mg/m\^2) iv.on day 2 in Cycle 1 followed by 75mg/m\^2 iv.on day 1 in Cycles 2 to 8.
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
RECRUITINGFudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
RECRUITINGObjective response rate (ORR)
ORR was defined as percentage of participants with partial response (PR) or complete response (CR) determined on the basis of investigator assessments.
Time frame: Baseline up to week 24(Baseline up to 8 cycles)
Duration of Response (DOR)
DOR was defined as the time from the date of initial confirmed PR or CR to the date of disease progression or death within the study.
Time frame: up to week 120
Progression-free survival (PFS)
PFS was defined as the time from randomization to the first occurrence of disease progression or death from any cause, whichever occurred first, on the basis of investigator assessments.
Time frame: up to week 120
Disease control rate(DCR)
DCR was defined as the percentage of participants with best overall response of CR, PR, stable disease (SD) and Non-CR/Non-progressive disease (PD).
Time frame: up to week 120
Overall survival (OS)
OS was defined as the time from the date of randomization to the date of death from any cause.
Time frame: up to week 120
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.