NRG-HN010

Open to Accrual

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A Controlled, Randomized Phase II Trial of Docetaxel Plus Trastuzumab Versus Ado-Trastuzumab Emtansine for Recurrent, Metastatic, or Treatment-Naïve, Unresectable Her2-Positive Salivary Gland Cancer

Principal Investigator

Alan L. Ho, MD, PhD,

Status

Open to Accrual

Date Opened To Accrual

September 30 2022

Disease Site

Head and Neck [HN]

Head and Neck

Phase

Developmental Therapeutics

Primary Objective

To determine if ado-trastuzumab emtansine (T-DM1) shows better progression-free survival (PFS) when compared to docetaxel plus trastuzumab (TH) in recurrent and/or metastatic (R/M) HER2-positive salivary gland cancer (SGC) patients who have not previously received HER2 therapy for unresectable or recurrent and/or metastatic disease, as determined by local assessment.

Patient Population

Recurrent, metastatic, or treatment-naïve, unresectable HER2-positive salivary gland cancer (SGC). Pathologically proven diagnosis of HER2-positive SGC based on local site immunohistochemistry (IHC), fluorescent in-situ hybridization (FISH), or local/commercial next-generation sequencing (NGS) is required.

Target Accrual

116

Protocol Documents

Available via the National Cancer Institute (NCI) Cancer Trials Support Unit (CTSU) website.

Other

NRG-HN010 Study Overview by Stuart Wong, MD

Patient Study Webpage

To learn more about this study, visit the Patient Study Webpage.

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