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.

Intas Pharmaceuticals Ltd0 个研究点目标入组 120 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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•The patient is willing to give written, signed and dated, informed consent to participate in the study before initiating any study related procedures
•Patient must have histopathologically /cytologically confirmed breast cancer
•Patient must have metastatic breast cancer after failure of prior combination chemotherapy or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated
•Patient with adequate bone marrow, renal and hepatic function

•Patient who has a history of hypersensitivity reactions to drugs formulated with Cremophor EL.
•Patient who was previously exposed to Taxane Injection
•Patient who has taken more than 1 prior chemotherapy treatment/regimen for metastatic breast cancer

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