An Open Label, Randomized, Multiple-Dose, Parallel Study to Evaluate Efficacy and Safety of Intravenous Infusion of Nanosomal Paclitaxel Lipid Suspension (Intas Pharmaceuticals Ltd.) and TaxolÂ® (Paclitaxel Injection Concentrate, Bristol-Myers Squibb.) in Metastatic Breast Cancer Patients after failure of prior chemotherapy. - NA

Intas Pharmaceuticals Ltd0 个研究点目标入组 54 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.The patient willing to give written, signed and dated, informed consent to participate in the study before initiating any study related procedures
•2.Patient must have histopathologically /cytologically confirmed breast cancer
•3.Have at least one measurable lesion as per the RECIST criteria (Version 1.1)
•4.Patients with life expectancy of at least 6 months.
•5.Patient must have negative serum pregnancy test at screening

•1.Patient who has already exposed to Taxane Injection
•2.Any of the following cardiac conditions:
•Unstable angina
•Myocardial infarction within the past 6 months
•Severe uncontrolled ventricular arrhythmias
•Clinically significant pericardial disease
•Electrocardiographic evidence of acute ischemia or active conduction system abnormality
•History of cardiac disease that met the NYHA Classification class 2 or greater
•3.Known history of drug addiction within last 1 year
•4.Patients with known CNS lesions (brain metastasis or carcinomatous meningitis).

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