Actively Recruiting
Testing the Use of Ado-Trastuzumab Emtansine Compared to the Usual Treatment (Chemotherapy With Docetaxel Plus Trastuzumab) or Trastuzumab Deruxtecan for Recurrent, Metastatic, or Unresectable HER2-Expressing Salivary Gland Cancers
Led by NRG Oncology · Updated on 2026-05-04
146
Participants Needed
150
Research Sites
282 weeks
Total Duration
On this page
Sponsors
N
NRG Oncology
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase II trial compares the effect of usual treatment of docetaxel chemotherapy plus trastuzumab, to ado-emtansine (T-DM1) in patients with HER2-postive salivary gland cancer that has come back (recurrent), that has spread from where it first started (primary site) to other places in the body, or cannot be removed by surgery (unresectable). This trial is also testing how well trastuzumab deruxtecan works in treating patients with HER2-low recurrent or metastatic salivary gland cancer. Trastuzumab is a form of targeted therapy because it works by attaching itself to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors. When trastuzumab attaches to HER2 receptors, the signals that tell the cells to grow are blocked and the cancer cell may be marked for destruction by body's immune system. Trastuzumab emtansine contains trastuzumab, linked to a chemotherapy drug called emtansine. Trastuzumab attaches to HER2 positive cancer cells in a targeted way and delivers emtansine to kill them. Trastuzumab deruxtecan is a monoclonal antibody called traztuzumab, linked to a chemotherapy drug called deruxtecan. Trastuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors and delivers deruxtecan to kill them. Docetaxel is in a class of medications called taxanes. It stops cancer cells from growing and dividing and may kill them. Trastuzumab emtansine may work better compared to usual treatment of chemotherapy with docetaxel and trastuzumab or trastuzumab deruxtecan in treating patients with recurrent, metastatic or unresectable salivary gland cancer.
CONDITIONS
Official Title
Testing the Use of Ado-Trastuzumab Emtansine Compared to the Usual Treatment (Chemotherapy With Docetaxel Plus Trastuzumab) or Trastuzumab Deruxtecan for Recurrent, Metastatic, or Unresectable HER2-Expressing Salivary Gland Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of HER2-positive or HER2-low expressing recurrent or metastatic salivary gland cancer confirmed by pathology
- HER2-positive patients meet specific criteria by immunohistochemistry, FISH, or next-generation sequencing
- HER2-low patients meet specific criteria by immunohistochemistry or FISH
- Patients have unresectable disease, recurrent, or metastatic cancer confirmed by imaging
- Patients with treated brain metastases with no progression or stable brain metastases not requiring immediate treatment
- Measurable or non-measurable disease by RECIST v1.1 for HER2-positive; measurable disease for HER2-low patients
- History and physical exam within 30 days before registration
- Recent imaging (CT or MRI) of neck, chest, and abdomen/pelvis within 60 days before registration
- Age 18 years or older
- Left ventricular ejection fraction (LVEF) 50% or higher within 30 days before registration
- Performance status ECOG 0-2 within 14 days before registration
- Adequate blood counts: ANC ≥ 1,500/mm³, platelets ≥ 100,000/mm³, hemoglobin ≥ 9.0 g/dL (transfusion allowed for HER2-positive patients)
- Kidney function with serum creatinine ≤ 1.5 times upper limit or creatinine clearance ≥ 30 mL/min within 14 days before registration
- Liver function within limits based on cohort and liver metastases status
- HIV patients on effective therapy with undetectable viral load eligible
- Hepatitis B patients with undetectable viral load on therapy; immune patients eligible
- Hepatitis C patients cured or on treatment with undetectable viral load eligible
- Negative pregnancy test for persons of childbearing potential within 14 days prior to registration
- Willingness to use effective contraception during treatment and for 7 months after last dose
- Recovery from prior chemotherapy or palliative radiotherapy toxicities to grade 1 or less
- Patients with prior or concurrent malignancies that do not interfere with study
- Signed informed consent and authorization to release personal health information
You will not qualify if you...
- Prior systemic therapy for HER2-positive salivary gland cancer in the unresectable or metastatic setting
- For HER2-low cohort, prior HER2-directed therapy for unresectable or metastatic disease
- Severe active comorbidities including unstable angina, recent myocardial infarction, severe heart failure
- Persistent severe electrolyte abnormalities that cannot be corrected
- Active infections requiring intravenous antibiotics, antivirals, or antifungals
- Grade 3 or higher peripheral neuropathy (HER2-positive cohort only)
- Interstitial lung disease, pulmonary fibrosis, pneumonitis, or related lung conditions
- Significant bleeding events (grade 3 or higher) within 28 days prior to registration
- Allergic reactions to trastuzumab, ado-trastuzumab emtansine, docetaxel, or trastuzumab deruxtecan or their components
- Exceeding cumulative dose limits of certain anthracyclines
- For HER2-low cohort, receipt of live attenuated vaccines within 30 days prior to first dose
- Pregnancy or unwillingness to stop nursing
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 150 locations
1
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama, United States, 35233
Active, Not Recruiting
2
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010
Active, Not Recruiting
3
Kaiser Permanente Dublin
Dublin, California, United States, 94568
Actively Recruiting
4
Kaiser Permanente-Fremont
Fremont, California, United States, 94538
Actively Recruiting
5
Kaiser Permanente Fresno Orchard Plaza
Fresno, California, United States, 93720
Actively Recruiting
6
Kaiser Permanente-Fresno
Fresno, California, United States, 93720
Actively Recruiting
7
City of Hope at Irvine Lennar
Irvine, California, United States, 92618
Active, Not Recruiting
8
Kaiser Permanente- Modesto MOB II
Modesto, California, United States, 95356
Actively Recruiting
9
Kaiser Permanente-Modesto
Modesto, California, United States, 95356
Actively Recruiting
10
Kaiser Permanente-Oakland
Oakland, California, United States, 94611
Actively Recruiting
11
Stanford Cancer Institute Palo Alto
Palo Alto, California, United States, 94304
Actively Recruiting
12
Kaiser Permanente-Roseville
Roseville, California, United States, 95661
Actively Recruiting
13
Kaiser Permanente Downtown Commons
Sacramento, California, United States, 95814
Actively Recruiting
14
Kaiser Permanente-South Sacramento
Sacramento, California, United States, 95823
Actively Recruiting
15
Kaiser Permanente-San Francisco
San Francisco, California, United States, 94115
Actively Recruiting
16
UCSF Medical Center-Mission Bay
San Francisco, California, United States, 94158
Suspended
17
Kaiser Permanente-Santa Teresa-San Jose
San Jose, California, United States, 95119
Actively Recruiting
18
Kaiser Permanente San Leandro
San Leandro, California, United States, 94577
Actively Recruiting
19
Kaiser San Rafael-Gallinas
San Rafael, California, United States, 94903
Actively Recruiting
20
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California, United States, 95051
Actively Recruiting
21
Kaiser Permanente-Santa Rosa
Santa Rosa, California, United States, 95403
Actively Recruiting
22
Kaiser Permanente-South San Francisco
South San Francisco, California, United States, 94080
Actively Recruiting
23
Kaiser Permanente-Vallejo
Vallejo, California, United States, 94589
Actively Recruiting
24
Kaiser Permanente-Walnut Creek
Walnut Creek, California, United States, 94596
Actively Recruiting
25
UCHealth University of Colorado Hospital
Aurora, Colorado, United States, 80045
Actively Recruiting
26
UCHealth Highlands Ranch Hospital
Highlands Ranch, Colorado, United States, 80129
Actively Recruiting
27
Emory University Hospital Midtown
Atlanta, Georgia, United States, 30308
Actively Recruiting
28
Kaiser Permanente Moanalua Medical Center
Honolulu, Hawaii, United States, 96819
Actively Recruiting
29
Saint Luke's Cancer Institute - Boise
Boise, Idaho, United States, 83712
Actively Recruiting
30
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho, United States, 83619
Actively Recruiting
31
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho, United States, 83642
Actively Recruiting
32
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho, United States, 83687
Actively Recruiting
33
Saint Luke's Cancer Institute - Twin Falls
Twin Falls, Idaho, United States, 83301
Actively Recruiting
34
Carle at The Riverfront
Danville, Illinois, United States, 61832
Actively Recruiting
35
Carle Physician Group-Effingham
Effingham, Illinois, United States, 62401
Actively Recruiting
36
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois, United States, 61938
Actively Recruiting
37
Memorial Hospital East
Shiloh, Illinois, United States, 62269
Actively Recruiting
38
Carle Cancer Center
Urbana, Illinois, United States, 61801
Actively Recruiting
39
McFarland Clinic - Ames
Ames, Iowa, United States, 50010
Active, Not Recruiting
40
UI Health Care Mission Cancer and Blood - Ankeny Clinic
Ankeny, Iowa, United States, 50023
Actively Recruiting
41
Saint Anthony Regional Hospital
Carroll, Iowa, United States, 51401
Actively Recruiting
42
UI Health Care Mission Cancer and Blood - West Des Moines Clinic
Clive, Iowa, United States, 50325
Actively Recruiting
43
Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
Actively Recruiting
44
UI Health Care Mission Cancer and Blood - Des Moines Clinic
Des Moines, Iowa, United States, 50309
Actively Recruiting
45
Broadlawns Medical Center
Des Moines, Iowa, United States, 50314
Actively Recruiting
46
Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
Actively Recruiting
47
UI Health Care Mission Cancer and Blood - Laurel Clinic
Des Moines, Iowa, United States, 50314
Actively Recruiting
48
UI Healthcare Mission Cancer and Blood - Fort Dodge
Fort Dodge, Iowa, United States, 50501
Actively Recruiting
49
UI Health Care Mission Cancer and Blood - Waukee Clinic
Waukee, Iowa, United States, 50263
Actively Recruiting
50
The Iowa Clinic PC
West Des Moines, Iowa, United States, 50266
Actively Recruiting
51
HaysMed
Hays, Kansas, United States, 67601
Actively Recruiting
52
University of Kansas Cancer Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
53
Lawrence Memorial Hospital
Lawrence, Kansas, United States, 66044
Actively Recruiting
54
The University of Kansas Cancer Center - Olathe
Olathe, Kansas, United States, 66061
Actively Recruiting
55
University of Kansas Cancer Center-Overland Park
Overland Park, Kansas, United States, 66210
Actively Recruiting
56
University of Kansas Hospital-Indian Creek Campus
Overland Park, Kansas, United States, 66211
Actively Recruiting
57
Salina Regional Health Center
Salina, Kansas, United States, 67401
Actively Recruiting
58
University of Kansas Health System Saint Francis Campus
Topeka, Kansas, United States, 66606
Actively Recruiting
59
University of Kansas Hospital-Westwood Cancer Center
Westwood, Kansas, United States, 66205
Actively Recruiting
60
University of Kentucky/Markey Cancer Center
Lexington, Kentucky, United States, 40536
Actively Recruiting
61
UPMC Western Maryland
Cumberland, Maryland, United States, 21502
Actively Recruiting
62
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
63
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Active, Not Recruiting
64
Weisberg Cancer Treatment Center
Farmington Hills, Michigan, United States, 48334
Active, Not Recruiting
65
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota, United States, 56601
Actively Recruiting
66
Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
Actively Recruiting
67
Fairview Southdale Hospital
Edina, Minnesota, United States, 55435
Actively Recruiting
68
Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Actively Recruiting
69
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415
Actively Recruiting
70
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
71
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota, United States, 55416
Actively Recruiting
72
Regions Hospital
Saint Paul, Minnesota, United States, 55101
Actively Recruiting
73
United Hospital
Saint Paul, Minnesota, United States, 55102
Actively Recruiting
74
Siteman Cancer Center at Saint Peters Hospital
City of Saint Peters, Missouri, United States, 63376
Actively Recruiting
75
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri, United States, 63141
Actively Recruiting
76
University Health Truman Medical Center
Kansas City, Missouri, United States, 64108
Actively Recruiting
77
University of Kansas Cancer Center - North
Kansas City, Missouri, United States, 64154
Actively Recruiting
78
University of Kansas Cancer Center - Lee's Summit
Lee's Summit, Missouri, United States, 64064
Actively Recruiting
79
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
80
Siteman Cancer Center-South County
St Louis, Missouri, United States, 63129
Actively Recruiting
81
Siteman Cancer Center at Christian Hospital
St Louis, Missouri, United States, 63136
Actively Recruiting
82
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire, United States, 03756
Actively Recruiting
83
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
84
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States, 07748
Actively Recruiting
85
Memorial Sloan Kettering Bergen
Montvale, New Jersey, United States, 07645
Actively Recruiting
86
University of New Mexico Cancer Center
Albuquerque, New Mexico, United States, 87106
Actively Recruiting
87
Memorial Sloan Kettering Commack
Commack, New York, United States, 11725
Actively Recruiting
88
Memorial Sloan Kettering Westchester
East White Plains, New York, United States, 10604
Actively Recruiting
89
Mount Sinai Chelsea
New York, New York, United States, 10011
Active, Not Recruiting
90
Mount Sinai Hospital
New York, New York, United States, 10029
Actively Recruiting
91
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
92
Memorial Sloan Kettering Nassau
Uniondale, New York, United States, 11553
Actively Recruiting
93
Sanford Bismarck Medical Center
Bismarck, North Dakota, United States, 58501
Actively Recruiting
94
Sanford Broadway Medical Center
Fargo, North Dakota, United States, 58122
Actively Recruiting
95
Sanford Roger Maris Cancer Center
Fargo, North Dakota, United States, 58122
Actively Recruiting
96
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio, United States, 45219
Actively Recruiting
97
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Active, Not Recruiting
98
Trinity's Tony Teramana Cancer Center
Steubenville, Ohio, United States, 43952
Actively Recruiting
99
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio, United States, 45069
Actively Recruiting
100
Cancer Centers of Southwest Oklahoma Research
Lawton, Oklahoma, United States, 73505
Actively Recruiting
101
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
102
UPMC Altoona
Altoona, Pennsylvania, United States, 16601
Actively Recruiting
103
UPMC-Heritage Valley Health System Beaver
Beaver, Pennsylvania, United States, 15009
Actively Recruiting
104
UPMC Hillman Cancer Center at Butler Health System
Butler, Pennsylvania, United States, 16001
Actively Recruiting
105
UPMC Camp Hill
Camp Hill, Pennsylvania, United States, 17011
Active, Not Recruiting
106
Carlisle Regional Cancer Center
Carlisle, Pennsylvania, United States, 17015
Actively Recruiting
107
UPMC Hillman Cancer Center - Passavant - Cranberry
Cranberry Township, Pennsylvania, United States, 16066
Actively Recruiting
108
UPMC Hillman Cancer Center Erie
Erie, Pennsylvania, United States, 16505
Actively Recruiting
109
UPMC Cancer Center at UPMC Horizon
Farrell, Pennsylvania, United States, 16121
Actively Recruiting
110
UPMC Cancer Centers - Arnold Palmer Pavilion
Greensburg, Pennsylvania, United States, 15601
Actively Recruiting
111
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
Harrisburg, Pennsylvania, United States, 17109
Actively Recruiting
112
IRMC Cancer Center
Indiana, Pennsylvania, United States, 15701
Actively Recruiting
113
UPMC-Johnstown/John P. Murtha Regional Cancer Center
Johnstown, Pennsylvania, United States, 15901
Actively Recruiting
114
UPMC Cancer Center at UPMC McKeesport
McKeesport, Pennsylvania, United States, 15132
Actively Recruiting
115
UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
Mechanicsburg, Pennsylvania, United States, 17050
Actively Recruiting
116
UPMC Hillman Cancer Center - Monroeville
Monroeville, Pennsylvania, United States, 15146
Actively Recruiting
117
UPMC Hillman Cancer Center in Coraopolis
Moon Township, Pennsylvania, United States, 15108
Actively Recruiting
118
UPMC Hillman Cancer Center - Part of Frick Hospital
Mount Pleasant, Pennsylvania, United States, 15666
Actively Recruiting
119
UPMC Cancer Center-Natrona Heights
Natrona Heights, Pennsylvania, United States, 15065
Actively Recruiting
120
UPMC Hillman Cancer Center - New Castle
New Castle, Pennsylvania, United States, 16105
Actively Recruiting
121
Arnold Palmer Cancer Center Medical Oncology Norwin
North Huntingdon, Pennsylvania, United States, 15642
Actively Recruiting
122
UPMC-Saint Margaret
Pittsburgh, Pennsylvania, United States, 15215
Actively Recruiting
123
UPMC-Mercy Hospital
Pittsburgh, Pennsylvania, United States, 15219
Actively Recruiting
124
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
125
UPMC-Passavant Hospital
Pittsburgh, Pennsylvania, United States, 15237
Actively Recruiting
126
UPMC-Saint Clair Hospital Cancer Center
Pittsburgh, Pennsylvania, United States, 15243
Actively Recruiting
127
UPMC Cancer Center at UPMC Northwest
Seneca, Pennsylvania, United States, 16346
Actively Recruiting
128
UPMC Cancer Center-Uniontown
Uniontown, Pennsylvania, United States, 15401
Actively Recruiting
129
UPMC Cancer Center-Washington
Washington, Pennsylvania, United States, 15301
Actively Recruiting
130
Divine Providence Hospital
Williamsport, Pennsylvania, United States, 17754
Actively Recruiting
131
UPMC Memorial
York, Pennsylvania, United States, 17408
Actively Recruiting
132
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
133
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota, United States, 57104
Actively Recruiting
134
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, United States, 57117-5134
Actively Recruiting
135
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
136
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, United States, 84112
Actively Recruiting
137
Dartmouth Cancer Center - North
Saint Johnsbury, Vermont, United States, 05819
Suspended
138
VCU Massey Comprehensive Cancer Center
Richmond, Virginia, United States, 23298
Actively Recruiting
139
Swedish Cancer Institute-Issaquah
Issaquah, Washington, United States, 98029
Actively Recruiting
140
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Actively Recruiting
141
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin, United States, 54701
Actively Recruiting
142
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin, United States, 54449
Actively Recruiting
143
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Actively Recruiting
144
Marshfield Medical Center - Minocqua
Minocqua, Wisconsin, United States, 54548
Actively Recruiting
145
ProHealth D N Greenwald Center
Mukwonago, Wisconsin, United States, 53149
Actively Recruiting
146
ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin, United States, 53066
Actively Recruiting
147
Marshfield Medical Center-Rice Lake
Rice Lake, Wisconsin, United States, 54868
Actively Recruiting
148
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin, United States, 54482
Actively Recruiting
149
UW Cancer Center at ProHealth Care
Waukesha, Wisconsin, United States, 53188
Actively Recruiting
150
Marshfield Medical Center - Weston
Weston, Wisconsin, United States, 54476
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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