Spots Global Cancer Trial Database for A Study of U3-1402 (Patritumab Deruxtecan) in Subjects With Metastatic Breast Cancer

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Trial Identification

Brief Title: A Study of U3-1402 (Patritumab Deruxtecan) in Subjects With Metastatic Breast Cancer

Official Title: A Phase II Study of U3-1402 (Patritumab Deruxtecan) in Patients With Metastatic Breast Cancer

Study ID: NCT04699630

Conditions

Metastatic Breast Cancer

Locally Advanced Breast Cancer

Interventions

U3-1402

Study Description

Brief Summary: This study is to evaluate safety and efficacy of an antibody drug conjugate U3-1402 (patritumab deruxtecan) in patients with locally advanced or metastatic breast cancer (MBC).

Detailed Description: U3-1402 (Patritumab Deruxtecan) is an antibody drug conjugate comprising a recombinant fully human anti HER3 monoclonal antibody linked to a linker containing topoisomerase I inhibitor. This is a phase II study of U3-1402 (patritumab deruxtecan) in subjects with MBC. The study will be conducted in 3 parts (Part A , Part B, and Part Z). All enrolled subjects in Part A will undergo pretreatment biopsies to determine if subjects with particular biomarker expression (ER/PR/HER2/HER3) show preliminary efficacy. Part B will enroll subgroups of participants that are metastatic, hormone receptor-positive (HR+) HER2-negative or triple-negative (mTNBC) regardless of HER3 expression that were defined from Part A analysis. Part Z will enroll participants with HER2- positive (HER2+) MBC.