A Study to Evaluate the Efficacy and Safety of the Combination of TQ-B211 Plus Docetaxel in Patients With HER2-positive MBC.

STATUS

Recruiting
participants needed

338
sponsor

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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Updated on 19 February 2024

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cancer

breast cancer

absolute neutrophil count

measurable disease

neutrophil count

docetaxel

targeted therapy

ejection fraction

trastuzumab

herceptin

aptt

stage iv breast cancer

creatinine clearance rate

recurrent 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.

Details

Condition	HER2-positive Metastatic Breast Cancer
Age	18years - 75years
Treatment	Docetaxel, TQ-B211, Herceptin®
Clinical Study Identifier	NCT04385563
Sponsor	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Ability to give written informed consent
	Age18 and 75,female
	Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1Life 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)1.5109/L Platelets 100 x 109/L Hemoglobin 90 g/L hemameba3.0109/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
	x 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 ratioINR1.5Activated partial thromboplastin time or partial thromboplastin time 1.5ULN
	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 drugsatrial 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

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A Study to Evaluate the Efficacy and Safety of the Combination of TQ-B211 Plus Docetaxel in Patients With HER2-positive MBC.