NCT04385563Unknown3 期
A Phase III,Randomized,Multicenter,Double-blind Clinical Trail to Evaluate the Efficacy,Safety and Immunogenicity of the Combination of TQ-B211 Plus Docetaxel Versus Herceptin® Plus Docetaxel as First-line Treatment in Patients With HER2-positive MBC.
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 338
- 试验地点
- 2
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
TQ-B211 + docetaxel
Experimental
Participants will be administered TQ-B211 plus docetaxel once every three weeks(Q3W) in cycles up to cycle 8.
干预措施: docetaxel (Drug)
Herceptin®+docetaxel
Active Comparator
Participants will be administered Herceptin® plus docetaxel Q3W in cycles up to cycle 8.
干预措施: Herceptin® (Drug)
Herceptin®+docetaxel
Active Comparator
Participants will be administered Herceptin® plus docetaxel Q3W in cycles up to cycle 8.
干预措施: docetaxel (Drug)
TQ-B211 + docetaxel
Experimental
Participants will be administered TQ-B211 plus docetaxel once every three weeks(Q3W) in cycles up to cycle 8.
干预措施: TQ-B211 (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: Baseline up to week 24（Baseline up to 8 cycles）
ORR was defined as percentage of participants with partial response (PR) or complete response (CR) determined on the basis of investigator assessments.
次要结局
- Duration of Response (DOR)(up to week 120)
- Overall survival (OS)(up to week 120)
- Progression-free survival (PFS)(up to week 120)
- Disease control rate(DCR)(up to week 120)
研究者
研究点 (2)
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