HER2-positive Metastatic Breast Cancer
Conditions
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 chosen as the comparator in the control group,as it represents a common first-line treatment option used in HER2+ MBC population in China.
Interventions
DRUGTQ-B211
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.
DRUGHerceptin®
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.
DRUGdocetaxel
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.
Sponsors
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective response rate (ORR) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Response (DOR) | up to week 120 | 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. |
| Progression-free survival (PFS) | up to week 120 | 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. |
| Disease control rate(DCR) | up to week 120 | 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). |
| Overall survival (OS) | up to week 120 | OS was defined as the time from the date of randomization to the date of death from any cause. |
Countries
China
Contacts
Primary ContactXi chun Hu, Doctor
Outcome results
None listed