A Phase IV Multi-Centric, Post-Marketing Study Evaluating the Safety, Immunogenicity and Efficacy of the Marketed Formulation of Hetero-Trastuzumab in Female Patients with HER2+ Breast Cancer. - NI

Hetero Biopharma Limited0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年1月22日

试验速览

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•1. Female patients of age 18 and above
•2. Patients willing to give written, signed, and dated informed consent to participate in the study
•3. Patients with breast cancer with evidence of HER2-overexpression by immunohistochemistry (IHC) or HER2 gene amplification by fluorescence in situ hybridization (FISH) or positive chromogenic in-situ hybridization (CISH) result.
•4. Patients with any other approved indication(s) as per the prescribing information at the discretion of principal investigator

•1. Patients with history of hypersensitivity to the trastuzumab or to any of the excipients, or to murine proteins or any other chemotherapeutic agent planned along with Trastuzumab
•2. Male patients with breast cancer
•3. Patients treated with Trastuzumab as (neo)adjuvant within 12 months or for metastatic breast cancer (Hetero-Trastuzumab use for MBC is allowed)
•4. Patients with symptomatic intrinsic lung disease or with extensive tumor involvement of the lungs, resulting in dyspnea at rest
•5. Patients with a history or evidence of cardiovascular diseases including congestive heart failure (CHF) of Grade IV New York Heart Association (NYHA) criteria, or serious cardiac arrhythmia, unstable angina pectoris, myocardial infarction
•6. Patients who are pregnant or a nursing mother.
•7. Patients received treatment with investigational drug in the last 90 days

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