A single blind, comparative, multicentre, randomized study of the efficacy and safety of Pegstim, solution for subcutaneous injection, 6 mg/0.6 mL (Cadila Healthcare Ltd., India), and Neulastim, solution for subcutaneous injection, 6 mg/0.6 mL (Amgen Manufacturing Limited, USA), in patients diagnosed with breast cancer who receive myelosuppressive chemotherapy.

Rus Biopharm LLC Russia0 个研究点目标入组 87 人开始时间: 待定最近更新: 2021年11月24日

研究概览

暂无简介。

•1 Verified diagnosis of breast cancer, stage I - III;
•2 Indication for the ADtx chemotherapy regimen (docetaxel 75 mg/m2 + doxorubicin 50 mg/m2); A need for >= 4 chemotherapy courses;
•3 Cumulative doxorubicin dose (during the whole life) not exceeding 550 mg/m2;
•4 Life expectancy exceeding 7 months;
•5 ECG Performance Status <= 2;
•6 Absolute neutrophil count >= 1.5Ã?109/L;
•7 Haemoglobin concentration >= 90 g/L;

•1 Body weight less than 45 kg;
•2 More than one line of chemotherapy administered prior to screening in connection with breast cancer;
•3 Preceding chemotherapy in connection with breast cancer less than 30 days prior to screening;
•4 A history of other malignant tumors, except for patients having no signs of disease for the last 5 years and patients with a fully cured basal cell carcinoma of the skin;
•5 A history of treatment with colony-stimulating factors;
•6 Radiation therapy within 4 weeks prior to screening;
•7 A history of bone marrow transplantation;
•8 Hypersensitivity to proteins obtained using E. coli, or to any other component of the investigational medicinal product / reference product;
•9 Hypersensitivity to doxorubicin and / or docetaxel and / or polysorbate 80;
•10 Hereditary fructose intolerance;

发起方

Rus Biopharm LLC Russia