A Randomized, Multiple-dose, Multicenter, Comparative Parallel Study toEvaluate the Efficacy, Safety and Pharmacokinetic Characteristics ofIntravenous Infusion of Trastuzumab Emtansine (Hetero) and ReferenceMedicinal Product (Trastuzumab Emtansine, Roche) in Patients of HER2-positive Metastatic breast cancer - TREMBC STUDY

Hetero Biopharma Limited0 个研究点目标入组 0 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. Female patients of age 18 to 65 years (both inclusive)
•2. Ability to comply with study and follow-up procedures and provide written informed consent
•3. Have pathologically confirmed, measurable invasive metastatic breast cancer.
•4. Documented evidence of HER2-overexpression
•5. Prior treatment for breast cancer in the adjuvant, unresectable, locally advanced, or metastatic setting
•6. Documented progression (which occur during or after most recent treatment or within 6 months
•7. Have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.

•1. Prior treatment with Trastuzumab emtansine, lapatinib, or capecitabine
•2. Peripheral neuropathy of grade 3 or higher
•3. Male patients with metastatic breast cancer
•4. Patients with current clinical or radiographic evidence of central nervous system
•5. Current dyspnea at rest due to complications of advanced malignancy or current requirement for continuous oxygen therapy
•6. Patients with an abnormal LVEF ( <50%)

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