Actively Recruiting
Post-op T-DM1 in HER-2+ Salivary Gland Carcinomas
Led by Dana-Farber Cancer Institute · Updated on 2026-04-13
37
Participants Needed
13
Research Sites
423 weeks
Total Duration
On this page
Sponsors
D
Dana-Farber Cancer Institute
Lead Sponsor
G
Genentech, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Post-op T-DM1 in HER-2+ Salivary Gland Carcinomas
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed, resectable stage II (with positive margins), III, IVA, or IVB locoregionally advanced salivary gland carcinoma
- Willing to provide tissue and blood samples before, during, and after treatment
- HER2 positive disease confirmed by IHC staining, FISH amplification, or tumor genomic sequencing
- Age 18 years or older
- ECOG performance status of 0 or 1
- Normal organ and marrow function within 14 days before registration
- Serum calcium, magnesium, and potassium levels within normal limits
- Cardiac function with left ventricular ejection fraction 50% or higher within 1 month prior to registration
- Ability to understand and sign informed consent
- Women of childbearing potential must have a negative pregnancy test within 72 hours before starting T-DM1
- Men sexually active with women of childbearing potential must agree to use effective contraception during and for 6 months after treatment
You will not qualify if you...
- Stage I or stage IVC (metastatic) disease or unresectable salivary gland cancer
- Prior radiation and/or chemotherapy for head and neck cancer
- History of prior HER2 directed therapy
- Active or uncontrolled infection
- Pregnant or lactating women
- Uncontrolled illness including symptomatic heart failure, unstable angina, cardiac arrhythmia, or psychiatric illness limiting compliance
- Known additional progressing malignancy requiring active treatment, except certain skin cancers or low-risk prostate cancer under surveillance
AI-Screening
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Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
Winship Cancer Institute, Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
2
University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
3
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
4
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Actively Recruiting
5
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
6
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States, 07748
Actively Recruiting
7
Memorial Sloan Kettering Bergen
Montvale, New Jersey, United States, 07645
Actively Recruiting
8
Memorial Sloan Kettering Commack
Commack, New York, United States, 11725
Actively Recruiting
9
Memorial Sloan Kettering Westchester
Harrison, New York, United States, 10604
Actively Recruiting
10
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021
Actively Recruiting
11
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
12
Memorial Sloan Kettering Nassau
Uniondale, New York, United States, 11553
Actively Recruiting
13
University of Washington Medical Center
Seattle, Washington, United States, 98195
Actively Recruiting
Research Team
G
Glenn J Hanna, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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