â??A prospective, randomized, multi-centric clinical study to compare Trastuzumab (Test Product, Zydus) with Trastuzumab (Reference Product, Roche/Genentech ) in patients with metastatic breast cancer.â??

Cadila Healthcare limited0 个研究点目标入组 102 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. Patients with histologically or cytologically confirmed uni-dimensionally measurable metastatic breast cancer.
•2. Have a strong Her-2 over-expression as described by a 3+
•3. Patients with ECOG performance status 0-2.

•1. Newly diagnosed metastatic breast cancer patients other than HER2 +ve patients. (Note since there is no treatment other than Trastuzumab for HER2+ve MBC such patients will not be excluded)
•2. Have a history of congestive heart failure (CHF)
•3. Have an abnormal LVEF
•4. History of myocardial infarction within 6 months before randomization.
•5. Have severe dyspnea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy.
•6. Have had prior mediastinal irradiation (except internal mammary-node irradiation for the present breast cancer).
•7. Have a history of hypersensitivity to the Trastuzumab 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 patient unsuitable for participation in the study.

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