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NRG / HN010

Trial Overview

Official Title

Testing the use of ado-trastuzumab emtansine compared to the usual treatment (chemotherapy with docetaxel plus trastuzumab) for recurrent, metastatic, or unresectable HER2-Positive salivary gland cancer.

Study Purpose

Will ado-trastuzumab emtansine extend the length of time without your cancer getting worse compared to standard of care?

Diagnosis

HER2 positive salivary gland cancer

Eligibility

HER2 positive salivary gland cancer that has come back, spread outside of your salivary gland or cannot be removed by surgery.

Intervention

Group 1—Standard of care Docetaxel and trastuzumab IV on day 1 of each cycle.  You will get 6 cycles of both drugs.  Each cycle is 21 days for a total of 18 weeks.  After 6 cycles you will continue on trastuzumab either alone or with docetaxel depending on how you are tolerating the chemotherapy.  You will continue trastuzumab alone, with or without docetaxel, until your disease gets worse, or the side effects become too severe.

 

Group 2---You will get a study drug called ado-trastuzumab emtansine.  You will get this drug IV on day 1 of each cycle.  Each cycle is 21 days and you will receive this drug until your disease gets worse or the side effects become too severe.

For more information, click the link below:

 

https://clinicaltrials.gov/study/NCT05408845?term=HN010&rank=1

 

Key Participation Requirements
Gender
male or female
Age
18 Years and older
Enrollment Status
Recruiting
Phase
Phase II
Methodist Health System Trial Code
HN010