RecruitingPhase 2NCT04620187

Post-op T-DM1 in HER-2+ Salivary Gland Carcinomas

A Phase II Study of Adjuvant Ado-trastuzumab Emtansine (T-DM1) in HER2-positive Salivary Gland Carcinomas

Sponsor

Dana-Farber Cancer Institute

Enrollment

37 participants

Start Date

Dec 24, 2020

Study Type

INTERVENTIONAL

Conditions

Salivary Gland Cancer HER2 Gene Mutation

Summary

This research is being done to see how safe and effective the use of the study drug Ado-trastuzumab (T) emtansine (DM1), T-DM1, and standard of care chemoradiation are when used together in treating HER2-positive salivary gland cancer. It will also examine the effectiveness of study drug Ado-trastuzumab (T) emtansine (DM1) on cancer recurrence.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing T-DM1 (a targeted antibody-drug combination used in breast cancer) as a post-surgery treatment for people with HER2-positive salivary gland cancers. HER2 is a protein found on some cancer cells, and drugs that target HER2 may help prevent the cancer from coming back. **You may be eligible if...** - You have been confirmed to have salivary gland cancer (any subtype) at stage II with positive surgical margins, or stage III–IVB - Your tumor is HER2-positive based on laboratory testing - You are willing to provide tissue samples and blood samples during the study **You may NOT be eligible if...** - Your tumor is HER2-negative - You have other serious health conditions that would make the treatment unsafe - You have received prior treatment targeting HER2 for this cancer - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAdo-trastuzumab (T) emtansine (T-DM1)

Intravenous infusion ever 21 days (3weeks) for 1 year (52 weeks)

RADIATIONStandard of Care Radiotherapy

Radiotherapy to shrink or kill tumors

DRUGStandard of Care Chemotherapy

Intravenous injection

Locations(13)

Winship Cancer Institute, Emory University

Atlanta, Georgia, United States

University of Chicago

Chicago, Illinois, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Memorial Sloan Kettering Basking Ridge

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen

Montvale, New Jersey, United States

Memorial Sloan Kettering Commack

Commack, New York, United States

Memorial Sloan Kettering Westchester

Harrison, New York, United States

David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Memorial Sloan Kettering Nassau

Uniondale, New York, United States

University of Washington Medical Center

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT04620187

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