CTRI/2018/07/014881已完成3 期
A Prospective, Randomized, Multicenter, Comparative, Openlabel,Parallel study to evaluate the Efficacy, Safety andPharmacokinetics of Test-Trastuzumab Emtansine (ZRC-3256;Cadila Healthcare Ltd) and Reference-TrastuzumabEmtansine(Kadcyla®, a product of Roche) inHER2- Positive Metastatic Breast Cancer Patients.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 168
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Female subjects of age 18 to 65 years (both inclusive).
- •2.Subject with pathologically (histologically or cytologically) confirmed, uni-dimensionally measurable invasive metastatic breast cancer.
- •3.Subjects with a strong HER-2 over-expression as described by a 3+ score by immunohistochemistry (IHC) or a positive fluorescence in-situ hybridization (FISH).
- •4.For the treatment of subjects with HER2-positive, metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. Subject should have either:
- •Received prior therapy for metastatic disease, or
- •Developed disease recurrence during or within six months of
- •completing adjuvant therapy.
- •5.Subject with Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- •6.Left ventricular ejection fraction (LVEF) >=50% by 2 D ECHO.
- •7.Subjects with following laboratory results:
- •Absolute neutrophil count >1500 cells/mm3
- •Platelet count >100,000 cells/mm3
- •Hemoglobin >=9.0 g/Dl
- •Total bilirubin <=1.5 upper limit of normal (ULN)
- •AST, ALT and alkaline phosphatase <= 2.5 X ULN.
- •8.Subjects must have recovered from all treatment related toxicities prior to randomization.
- •9.Pregnancy-related inclusions, including:
- •Subjects with negative serum pregnancy test at trial start
- •Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and till the end of study visit. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately.
- •10.Ability to comply with study and follow â?? up procedures and provide written informed consent.
- •11.Patient with life expectancy of minimum of 7 months at screening.
排除标准
- •1.Subject with history of Trastuzumab emtansine treatment.
- •2.Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease).
- •3.History of symptomatic chronic heart failure (New York Heart Association [NYHA] Classes II-IV) or serious cardiac arrhythmia requiring treatment.
- •4.Current uncontrolled hypertension (systolic blood pressure >150 mmHg and/or diastolic blood pressure >100 mmHg), or unstable angina.
- •5.Pregnancy or lactation.
- •6.Current known active infection with HIV, hepatitis B virus, or hepatitis C virus.
- •7.Have a history of hypersensitivity to the Trastuzumab emtansine or to drugs with similar chemical structures, or to any of the excipients, or to murine proteins.
- •8.Have any concurrent disease or condition that, in the opinion of the investigator, would make the subject unsuitable for participation in the study.
- •9.Any chemotherapy, hormonal therapy, radiotherapy or surgery for the treatment of breast cancer within 3 weeks of screening.
- •10.Have any concurrent disease or condition that, in the opinion of the investigator, would make the subject unsuitable for participation in the study.
- •11.Have any other medical or psychiatric condition that could compromise study participation.
- •12.Current clinical or radiographic evidence of Central nervous metastates.
研究者
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