A prospective, multicentric, randomized, open label, parallel group, comparative, two arms, safety, efficacy and pharmacokinetic study of Trastuzumab, (Manufactured by Intas Pharmaceuticals Limited, Biopharma Division, Ahmedabad, India) in comparison with Reference Biologic (Trastuzumab, Marketed by Roche) in the patients with HER2-Overexpressing Metastatic Breast Cancer. - NA

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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•1.The patient willing to give informed consent to participate in the study before initiating any study related procedures
•2.Female >=18 years and <=65 years of age at screening.
•3.Women with histologically/cytologically confirmed HER2 (human epidermal growth factor receptor 2)-Overexpressing metastatic breast cancer.
•4.Patients who are eligible for taxanes and Trastuzumab as per opinion of PI.
•5.Patient must have an adequate bone marrow, renal, cardiac and hepatic function.

•1.Patient with severely immunocompromised state.
•2.Chronic treatment with systemic steroids or another immunosuppressive agent.
•3.Clinically significant medical condition that, in opinion of the investigator, might place the patient at unacceptable risk for participation in this study
•4.Patients with an active, severe infection (e.g., tuberculosis, sepsis and opportunistic infections).
•5.Any malignancy in the last 2 years other than breast cancer except skin cancer or carcinoma in situ of the cervix

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