A Phase II Study of Ado-Trastuzumab Emtansine Compared to the Usual Treatment for Advanced HER2-Positive Salivary Gland Cancer

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Full Title

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 (NRG-HN010) (CIRB)

Purpose

In this study, researchers are comparing ado-trastuzumab emtansine with the usual treatment (docetaxel and trastuzumab) in people with recurrent, inoperable, or metastatic salivary gland cancer that makes the HER2 protein. Ado-trastuzumab emtansine is a monoclonal antibody (trastuzumab) linked to a chemotherapy drug (emtansine). Trastuzumab attaches to HER2 on cancer cells and delivers emtansine to kill them.

Participants in this study will be randomly assigned to receive either ado-trastuzumab emtansine or the usual treatment (docetaxel and trastuzumab). All of the medications used in this study are given intravenously (by vein).

Who Can Join

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have HER2-positive salivary gland cancer that has come back despite treatment, is inoperable, or has metastasized.
  • The serious side effects of previous treatments must go away before the study therapy is given. No prior treatment may have been given for advanced disease.
  • Patients must be able to walk and do routine activities for more than half of their normal waking hours.
  • This study is for people age 18 and older.

Contact

For more information about this study and to inquire about eligibility, please contact the office of Dr. Alan Ho at 646-608-3774.

Protocol

22-368

Phase

Phase II (phase 2)

Disease Status

Newly Diagnosed

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT05408845