Phase III Study of Trastuzumab Deruxtecan (T-DXd) with or without Pertuzumab versus Taxane, Trastuzumab and Pertuzumab in HER2-positive, First-line Metastatic Breast Cancer (DESTINY-Breast09)

HER2-positive metastatic breast cancer

PFS is defined as the time from date of randomisation until the date of objective radiological disease progression according to BICR using RECIST 1.1 or death by any cause.

PFS is defined as the time from date of randomisation until the date of objective radiological disease progression according to investigator assessment using RECIST 1.1 or death by any cause., OS is defined as the time from randomisation until the date of death due to any cause., ORR is defined as the proportion of participants who have a CR or PR, as determined by BICR and investigator assessment per RECIST 1.1. DoR is defined as the time from date of first detection of objective response until the date of objective radiological disease progression according to BICR and investigator assessment using RECIST 1.1 or death in the absence of progression., Time to second progression or death (PFS2) by Investigator assessment, Health related quality of life (HRQoL) using the European Organisation for Research and Treatment of Cancer (EORTC), Serum concentration of trastuzumab deruxtecan and pertuzumab, Immunogenicity of trastuzumab deruxtecan, alone or with pertuzumab., Safety and tolerability of trastuzumab deruxtecan, alone or with pertuzumab

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