Status:
UNKNOWN
A Study to Evaluate the Efficacy and Safety of the Combination of TQ-B211 Plus Docetaxel in Patients With HER2-positive MBC.
Lead Sponsor:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Conditions:
HER2-positive Metastatic Breast Cancer
Eligibility:
FEMALE
18-75 years
Phase:
PHASE3
Brief 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 cho...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 11 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2021
Estimated Enrollment :
338 Patients enrolled
Trial Details
Trial ID
NCT04385563
Start Date
November 11 2018
End Date
October 1 2021
Last Update
May 13 2020
Active Locations (2)
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1
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China, 150081
2
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200123