a study to evaluate the efficacy and safety of the combination of tq-b211 plus docetaxel in patients with her2-positive mbc.

Conditions: HER2-positive Metastatic Breast Cancer

Summary: 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.


Eligibility criteria:
inclusion criteria: * ability to give written informed consent. * age：≥18 and ≤75,female. * eastern cooperative oncology group (ecog) performance status of 0 or 1；life expectancy of at least 12 weeks. * histologically confirmed diagnosis as her2-positive metastatic or locally recurrent breast cancer that cannot be treated with radical surgery or radiotherapy. * no prior systematical chemotherapy, biotherapy or molecule-targeted therapy for metastatic breast cance. * patients must have a measurable disease according to recist v. 1.1 28 days before randomization. (disease in brain or bone will not be included) * left ventricular ejection fraction (lvef) ≥50 percent (%) * blood routine examination should meet the following conditions: absolute neutrophil count (anc)≥1.5×109/l platelets ≥100 x 109/l hemoglobin ≥90 g/l hemameba≥3.0×109/l ) * liver function should meet the following conditions: total bilirubin ≤1.5x upper limit of normal(uln); alanine aminotransferase (alt) and aspartate aminotransferase (ast) ≤3x uln if no liver involvement or ≤5x uln with liver involvement. -kidney function should meet the following conditions: cr (creatinine) ≤1.5x uln or ccr (creatinine clearance rate) ≥50 ml/min. * the coagulation function should meet the following conditions: international normalized ratio（inr）≤1.5；activated partial thromboplastin time or partial thromboplastin time ≤1.5×uln * female who meet the following criteria can participate in the study: no childbearing potential； female with childbearing potential: negative pregnancy test within 7 days before the first administration of the investigational drug; patients are not breastfeeding; contraception use must continue for the duration of study treatment and for at least 6 months after the last dose of study treatment. exclusion criteria: * not eligible for docetaxel combination therapy. * endocrine therapy within 2 weeks before randomization. * patients had received neoadjuvant or adjuvant therapy with herceptin 12 months before randomization. * patients had received neoadjuvant/adjuvant drugs containing other anthracycline or taxol 6 months before randomization. * patients had used chinese patent medicine or chinese herbal medicine with anti-cancer activity 2 weeks before randomization. * brain metastases with symptom/untreated brain metastases/other central nervous system(cns) metastases. treated cns metastases remain stable for at least 4 weeks before the study, and no evidence of cerebral edema, no sign for glucosinolates or anticonvulsants treatments. * patients with a previous malignancy within the past 5 years (other than curatively treated in situ carcinoma of the cervix, non-melanoma skin cancer and superficial bladder carcinoma). * hepatitis virus c(hcv) positive, hiv positive, syphilis positive, or hbsag positive and hepatitis virus b(hbv) dna titer in peripheral blood is beyond the normal range. * patients had received major surgical procedures (including open chest biopsy) major trauma (e.g. fracture) within 4 weeks before randomization, and there are unhealed wounds, ulcers or fractures at the time of screening or major surgery is expected during the study * patients have a history of hypertensive encephalopathy or a hypertension or an uncontrolled hypertension ( systolic blood pressure \>150mmhg or diastolic blood pressure \>100mmhg with antihypertensive drugs) * patients had a history of myocardial infarction 6 months before randomization; medical history of congestive heart failure in new york heart association classification (nyha)≥ grade ii,and a severe arrhythmia that cannot be controlled by drugs（atrial fibrillation and paroxysmal supraventricular tachycardia are excluded）;lvef had previously declined to less than 50% during or after new trastuzumab adjuvant or adjuvant therapy. * allergies to herceptin ®/ tq-b211 or the chemotherapies involved in this trial and their excipients. * history hypersensitivity to any study drug . * patients had participated in clinical trials of other antitumor drugs 4 weeks before randomization . * not eligible to join the study judged by investigators.