Phase
Condition
Carcinoma
Treatment
Trastuzumab Emtansine
Trastuzumab
Computed Tomography
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Pathologically (histologically or cytologically) proven diagnosis of HER2-positiveOR HER2-low expressing recurrent/metastatic salivary gland cancer (SGC)
HER2-positive cohort:
Note: The majority of HER2-positive SGCs are salivary duct carcinoma (SDCs), but to a lesser extent, other SGC subtypes can be HER2-positive (e.g., adenocarcinomas, mucoepidermoid carcinomas, etc.) and are eligibleto be included on the study. Additionally, pathologists may sign out SDCsunder other descriptors (e.g., ex-pleomorphic adenoma, adenocarcinoma),and these would be eligible if they are HER2-positive.
Note: HER2 evaluation based on local site immunohistochemistry (IHC),fluorescent in-situ hybridization (FISH), or local/commercialnext-generation sequencing (NGS) is required. Any one of the followingcriteria observed in a primary tumor or metastasis would meet the studydefinition for "HER2-positive":
Immunohistochemistry (IHC) (3+) per the College of AmericanPathologists (CAP) breast cancer guidelines
Gene amplification by FISH (HER2/CEP17 ratio >= 2.0)
Gene amplification by NGS (fold change >= 2)
HER2-low expressing cohort:
Note: Local HER2 evaluation by immunohistochemistry (IHC) or fluorescentin-situ hybridization (FISH) is required. Any one of the followingcriteria observed in a primary tumor or metastasis would meet the studydefinition for "HER2-low":
IHC 1+ per the College of American Pathologists (CAP) breast cancerguidelines
IHC 2+ without evidence of amplification by FISH
Patients with unresectable disease who are not candidates for curative surgery orradiation OR recurrent OR metastatic disease that is evident on radiologic imaging
Patients with treated brain metastases are eligible if follow-up brain imaging aftercentral nervous system (CNS)-directed therapy shows no evidence of progression
Patients with new or progressive brain metastases (active brain metastases) orleptomeningeal disease are eligible if the treating physician determines thatimmediate CNS specific treatment is not required and is unlikely to be requiredduring the first cycle of therapy
HER2-positive cohort: Measurable or non-measurable disease by the RECIST v1.1criteria. HER2-low expressing cohort: Measurable disease by the RECIST v1.1 criteria
History/physical examination within 30 days prior to registration
The following imaging within 60 days prior to registration:
CT or MRI of the neck (diagnostic quality with contrast, unlesscontraindicated) AND
CT scan of the chest (diagnostic quality with contrast, unless contraindicated)AND
If clinically indicated, CT or MRI of the abdomen and pelvis (diagnosticquality with contrast, unless contraindicated)
Age >= 18
Left ventricular ejection fraction (LVEF) >= 50% assessed by echocardiogram ormultigated acquisition (MUGA) scan within 30 days prior to registration
Zubrod (Eastern Cooperative Oncology Group [ECOG]) Performance Status of 0-2 within 14 days prior to registration
Absolute neutrophil count (ANC) >= 1,500 cells/mm^3 (within 14 days prior toregistration)
Platelets >= 100,000 cells/mm^3 (within 14 days prior to registration)
Hemoglobin >= 9.0 g/dL (within 14 days prior to registration)
HER2-positive cohort: Note: The use of transfusion or other intervention toachieve hemoglobin [Hgb] >= 9.0 g/dL is acceptable
HER2-low expressing cohort: Note: Transfusion (red blood cell or platelet) orgranulocyte-colony stimulating factor (granulocyte colony-stimulating factor [G-CSF]) is not allowed
Serum creatinine =< 1.5 x upper limit of normal (ULN) OR calculated creatinineclearance (CrCl) >= 30 mL/min by the Cockcroft-Gault formula (within 14 days priorto registration)
HER2-positive cohort: Total bilirubin =< 1.5 x ULN (within 14 days prior toregistration) (Not applicable to patients with known Gilbert's syndrome) (within 14days prior to registration)
HER2-positive cohort: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 1.5 x ULN (within 14 days prior to registration)
HER2-low expressing cohort: Total bilirubin ≤ 1.5 x ULN if no liver metastases; or < 3 x ULN in the presence of documented Gilbert's Syndrome or liver metastases (within 14 days prior to registration) (within 14 days prior to registration)
HER2-low expressing cohort: AST and ALT ≤ 3 x ULN if no liver metastases; or < 5 xULN with liver metastases (within 14 days prior to registration)
HER2-low expressing cohort: Serum albumin ≥ 2.5 g/dL (within 14 days prior toregistration)
Known human immunodeficiency virus (HIV) infected patients on effectiveanti-retroviral therapy with undetectable viral load within 6 months prior toregistration are eligible for this trial. Testing is not required for entry intoprotocol
For patients with known evidence of chronic hepatitis B virus (HBV) infection, theHBV viral load must be undetectable on suppressive therapy, if indicated
Note: Known positive test for hepatitis B virus surface antigen (HBV sAg)indicating acute or chronic infection would make the patient ineligible unlessthe viral load becomes undetectable on suppressive therapy. Patients who areimmune to hepatitis B (anti-hepatitis B surface antibody positive) are eligible (e.g., patients immunized against hepatitis B)
For patients with a known history of hepatitis C virus (HCV) infection, they musthave been treated and cured. For patients with HCV infection who are currently ontreatment, they are eligible if they have an undetectable HCV viral load
Note: Known positive test for hepatitis C virus ribonucleic acid (HCV RNA)indicating acute or chronic infection would make the patient ineligible unlessthe viral load becomes undetectable on suppressive therapy
Negative urine or serum pregnancy test (in persons of childbearing potential) within 14 days prior to registration. Childbearing potential is defined as any person whohas experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal
Willing to use highly effective contraceptives for participants of childbearingpotential (participants who may become pregnant or who may impregnate a partner)during therapy and for 7 months following last dose of study drug; this inclusion isnecessary because the treatment in this study may be significantly teratogenic.Women must refrain from donating eggs during this same period
Men with partners of childbearing potential must be willing to use a highlyeffective form of non-hormonal contraception or two effective forms of non-hormonalcontraception by the patient and/or partner, and to continue the use ofcontraception for the duration of study treatment and for at least 7 months afterthe last dose of study treatment. Male patients whose partners are pregnant shoulduse condoms for the duration of the pregnancy. Men must refrain from donating spermduring this same period
Prior to registration, patients who have had chemotherapy or palliative-intentradiotherapy must have all toxicities related to prior treatment recovered to ≤grade 1
Patients with a prior or concurrent malignancy whose natural history or treatmentdoes not have the potential to interfere with the safety or efficacy assessment ofthe investigational regimen are eligible for this trial
The patient or a legally authorized representative must provide study-specificinformed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information
Exclusion
Exclusion Criteria:
HER2-positive cohort: Prior systemic therapy for the study cancer in theunresectable or recurrent and/or metastatic disease setting
Note: Prior chemotherapy for a different cancer is allowed; prior androgenreceptor targeted therapy in any setting is allowed; prior systemic therapy,including HER2-directed therapies given as neoadjuvant therapy, adjuvanttherapy, and/or concurrently with radiation is allowed
HER2-low expressing cohort: HER2 directed therapy for unresectable or recurrent ormetastatic disease is not allowed
Severe, active co-morbidity defined as follows:
Unstable angina requiring hospitalization in the last 6 months
Myocardial infarction within the last 6 months
New York Heart Association Functional Classification III/IV (Note: Patientswith known history or current symptoms of cardiac disease, or history oftreatment with cardiotoxic agents, should have a clinical risk assessment ofcardiac function using the New York Heart Association FunctionalClassification.)
Persistent grade 3-4 (CTCAE version 5.0) electrolyte abnormalities that cannotbe reversed despite replacement as indicated by repeat testing
Patient must not have an active infection requiring IV antibiotics, antivirals,or antifungals
HER2-positive cohort only: >= grade 3 peripheral neuropathy
Interstitial lung disease or pulmonary fibrosis, organizing pneumonia (e.g.,bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, orevidence of active pneumonitis on chest CT scan
Any hemorrhage or bleeding event grade >= 3 within 28 days prior to registration
History of allergic reactions to compounds of similar chemical or biologiccomposition to: HER2-positive cohort: ado-trastuzumab emtansine, trastuzumab, and/ordocetaxel (or any of their excipients). HER2-low expressing cohort: DS-8201a (trastuzumab deruxtecan), trastuzumab
History of exposure to the following cumulative doses of anthracyclines:
Doxorubicin or liposomal doxorubicin > 500 mg/m^2
Epirubicin > 900 mg/m^2
Mitoxantrone > 120 mg/m^2
Note: If another anthracycline, or more than one anthracycline has been used,the cumulative dose must not exceed the equivalent of doxorubicin 500 mg/m^2
HER2-low expressing cohort only: Receipt of live, attenuated vaccine (messengerribonucleic acid [mRNA and replication deficient adenoviral vaccines are notconsidered attenuated live vaccines) within 30 days prior to the first dose ofDS-8201a (trastuzumab deruxtecan)
Pregnancy and individuals unwilling to discontinue nursing
Study Design
Study Description
Connect with a study center
University of Alabama at Birmingham Cancer Center
Birmingham, Alabama 35233
United StatesSite Not Available
City of Hope Comprehensive Cancer Center
Duarte, California 91010
United StatesSite Not Available
Kaiser Permanente Dublin
Dublin, California 94568
United StatesActive - Recruiting
Kaiser Permanente-Fremont
Fremont, California 94538
United StatesActive - Recruiting
Kaiser Permanente-Fresno
Fresno, California 93720
United StatesActive - Recruiting
City of Hope at Irvine Lennar
Irvine, California 92618
United StatesSite Not Available
Kaiser Permanente-Modesto
Modesto, California 95356
United StatesActive - Recruiting
Kaiser Permanente-Oakland
Oakland, California 94611
United StatesActive - Recruiting
Stanford Cancer Institute Palo Alto
Palo Alto, California 94304
United StatesActive - Recruiting
Kaiser Permanente-Roseville
Roseville, California 95661
United StatesActive - Recruiting
Kaiser Permanente Downtown Commons
Sacramento, California 95814
United StatesActive - Recruiting
Kaiser Permanente-South Sacramento
Sacramento, California 95823
United StatesActive - Recruiting
Kaiser Permanente-San Francisco
San Francisco, California 94115
United StatesActive - Recruiting
UCSF Medical Center-Mission Bay
San Francisco, California 94158
United StatesActive - Recruiting
Kaiser Permanente-Santa Teresa-San Jose
San Jose, California 95119
United StatesActive - Recruiting
Kaiser Permanente San Leandro
San Leandro, California 94577
United StatesActive - Recruiting
Kaiser San Rafael-Gallinas
San Rafael, California 94903
United StatesActive - Recruiting
Kaiser Permanente Medical Center - Santa Clara
Santa Clara, California 95051
United StatesActive - Recruiting
Kaiser Permanente-Santa Rosa
Santa Rosa, California 95403
United StatesActive - Recruiting
Kaiser Permanente-South San Francisco
South San Francisco, California 94080
United StatesActive - Recruiting
Kaiser Permanente-Vallejo
Vallejo, California 94589
United StatesActive - Recruiting
Kaiser Permanente-Walnut Creek
Walnut Creek, California 94596
United StatesActive - Recruiting
UCHealth University of Colorado Hospital
Aurora, Colorado 80045
United StatesActive - Recruiting
University of Colorado Hospital
Aurora, Colorado 80045
United StatesActive - Recruiting
UCHealth Highlands Ranch Hospital
Highlands Ranch, Colorado 80129
United StatesActive - Recruiting
Emory University Hospital Midtown
Atlanta, Georgia 30308
United StatesActive - Recruiting
Kaiser Permanente Moanalua Medical Center
Honolulu, Hawaii 96819
United StatesActive - Recruiting
Saint Luke's Cancer Institute - Boise
Boise, Idaho 83712
United StatesActive - Recruiting
Saint Luke's Cancer Institute - Fruitland
Fruitland, Idaho 83619
United StatesActive - Recruiting
Saint Luke's Cancer Institute - Meridian
Meridian, Idaho 83642
United StatesActive - Recruiting
Saint Luke's Cancer Institute - Nampa
Nampa, Idaho 83687
United StatesActive - Recruiting
Saint Luke's Cancer Institute - Twin Falls
Twin Falls, Idaho 83301
United StatesActive - Recruiting
Carle at The Riverfront
Danville, Illinois 61832
United StatesActive - Recruiting
Carle on Vermilion
Danville, Illinois 61832
United StatesActive - Recruiting
Carle Physician Group-Effingham
Effingham, Illinois 62401
United StatesActive - Recruiting
Carle Physician Group-Mattoon/Charleston
Mattoon, Illinois 61938
United StatesActive - Recruiting
Carle Cancer Center
Urbana, Illinois 61801
United StatesActive - Recruiting
McFarland Clinic - Ames
Ames, Iowa 50010
United StatesSite Not Available
McFarland Clinic PC - Ames
Ames, Iowa 50010
United StatesActive - Recruiting
Mercy Medical Center - Des Moines
Des Moines, Iowa 50314
United StatesActive - Recruiting
University of Kentucky/Markey Cancer Center
Lexington, Kentucky 40536
United StatesActive - Recruiting
UPMC Western Maryland
Cumberland, Maryland 21502
United StatesActive - Recruiting
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan 48109
United StatesActive - Recruiting
Wayne State University/Karmanos Cancer Institute
Detroit, Michigan 48201
United StatesSite Not Available
Weisberg Cancer Treatment Center
Farmington Hills, Michigan 48334
United StatesSite Not Available
Sanford Joe Lueken Cancer Center
Bemidji, Minnesota 56601
United StatesActive - Recruiting
Mercy Hospital
Coon Rapids, Minnesota 55433
United StatesActive - Recruiting
Fairview Southdale Hospital
Edina, Minnesota 55435
United StatesActive - Recruiting
Abbott-Northwestern Hospital
Minneapolis, Minnesota 55407
United StatesActive - Recruiting
Mayo Clinic in Rochester
Rochester, Minnesota 55905
United StatesActive - Recruiting
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park, Minnesota 55416
United StatesActive - Recruiting
Regions Hospital
Saint Paul, Minnesota 55101
United StatesActive - Recruiting
United Hospital
Saint Paul, Minnesota 55102
United StatesActive - Recruiting
Siteman Cancer Center at West County Hospital
Creve Coeur, Missouri 63141
United StatesActive - Recruiting
Siteman Cancer Center at Christian Hospital
Saint Louis, Missouri 63136
United StatesActive - Recruiting
Siteman Cancer Center-South County
Saint Louis, Missouri 63129
United StatesActive - Recruiting
Washington University School of Medicine
Saint Louis, Missouri 63110
United StatesActive - Recruiting
Siteman Cancer Center at Saint Peters Hospital
Saint Peters, Missouri 63376
United StatesActive - Recruiting
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
Lebanon, New Hampshire 03756
United StatesActive - Recruiting
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey 07920
United StatesActive - Recruiting
Memorial Sloan Kettering Monmouth
Middletown, New Jersey 07748
United StatesActive - Recruiting
Memorial Sloan Kettering Bergen
Montvale, New Jersey 07645
United StatesActive - Recruiting
Memorial Sloan Kettering Commack
Commack, New York 11725
United StatesActive - Recruiting
Memorial Sloan Kettering Westchester
Harrison, New York 10604
United StatesActive - Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United StatesActive - Recruiting
Mount Sinai Chelsea
New York, New York 10011
United StatesActive - Recruiting
Mount Sinai Hospital
New York, New York 10029
United StatesActive - Recruiting
Memorial Sloan Kettering Nassau
Uniondale, New York 11553
United StatesActive - Recruiting
Sanford Bismarck Medical Center
Bismarck, North Dakota 58501
United StatesActive - Recruiting
Sanford Broadway Medical Center
Fargo, North Dakota 58122
United StatesActive - Recruiting
Sanford Roger Maris Cancer Center
Fargo, North Dakota 58122
United StatesActive - Recruiting
University of Cincinnati Cancer Center-UC Medical Center
Cincinnati, Ohio 45219
United StatesActive - Recruiting
Ohio State University Comprehensive Cancer Center
Columbus, Ohio 43210
United StatesActive - Recruiting
Trinity's Tony Teramana Cancer Center
Steubenville, Ohio 43952
United StatesActive - Recruiting
University of Cincinnati Cancer Center-West Chester
West Chester, Ohio 45069
United StatesActive - Recruiting
Cancer Centers of Southwest Oklahoma Research
Lawton, Oklahoma 73505
United StatesActive - Recruiting
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma 73104
United StatesActive - Recruiting
UPMC Altoona
Altoona, Pennsylvania 16601
United StatesActive - Recruiting
UPMC-Heritage Valley Health System Beaver
Beaver, Pennsylvania 15009
United StatesActive - Recruiting
UPMC Hillman Cancer Center at Butler Health System
Butler, Pennsylvania 16001
United StatesActive - Recruiting
UPMC Camp Hill
Camp Hill, Pennsylvania 17011
United StatesSite Not Available
Carlisle Regional Cancer Center
Carlisle, Pennsylvania 17015
United StatesActive - Recruiting
UPMC Hillman Cancer Center - Passavant - Cranberry
Cranberry Township, Pennsylvania 16066
United StatesActive - Recruiting
UPMC Hillman Cancer Center Erie
Erie, Pennsylvania 16505
United StatesActive - Recruiting
UPMC Cancer Center at UPMC Horizon
Farrell, Pennsylvania 16121
United StatesActive - Recruiting
UPMC Cancer Centers - Arnold Palmer Pavilion
Greensburg, Pennsylvania 15601
United StatesActive - Recruiting
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
Harrisburg, Pennsylvania 17109
United StatesActive - Recruiting
IRMC Cancer Center
Indiana, Pennsylvania 15701
United StatesActive - Recruiting
UPMC-Johnstown/John P. Murtha Regional Cancer Center
Johnstown, Pennsylvania 15901
United StatesActive - Recruiting
UPMC Cancer Center at UPMC McKeesport
McKeesport, Pennsylvania 15132
United StatesActive - Recruiting
UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
Mechanicsburg, Pennsylvania 17050
United StatesActive - Recruiting
UPMC Hillman Cancer Center - Monroeville
Monroeville, Pennsylvania 15146
United StatesActive - Recruiting
UPMC Hillman Cancer Center in Coraopolis
Moon, Pennsylvania 15108
United StatesActive - Recruiting
UPMC Hillman Cancer Center - Part of Frick Hospital
Mount Pleasant, Pennsylvania 15666
United StatesActive - Recruiting
Arnold Palmer Cancer Center Medical Oncology Norwin
N. Huntingdon, Pennsylvania 15642
United StatesActive - Recruiting
UPMC Cancer Center-Natrona Heights
Natrona Heights, Pennsylvania 15065
United StatesActive - Recruiting
UPMC Hillman Cancer Center - New Castle
New Castle, Pennsylvania 16105
United StatesActive - Recruiting
UPMC-Mercy Hospital
Pittsburgh, Pennsylvania 15219
United StatesActive - Recruiting
UPMC-Passavant Hospital
Pittsburgh, Pennsylvania 15237
United StatesActive - Recruiting
UPMC-Saint Clair Hospital Cancer Center
Pittsburgh, Pennsylvania 15243
United StatesActive - Recruiting
UPMC-Saint Margaret
Pittsburgh, Pennsylvania 15215
United StatesActive - Recruiting
University of Pittsburgh Cancer Institute (UPCI)
Pittsburgh, Pennsylvania 15232
United StatesActive - Recruiting
UPMC Cancer Center at UPMC Northwest
Seneca, Pennsylvania 16346
United StatesActive - Recruiting
UPMC Cancer Center-Uniontown
Uniontown, Pennsylvania 15401
United StatesActive - Recruiting
UPMC Cancer Center-Washington
Washington, Pennsylvania 15301
United StatesActive - Recruiting
Divine Providence Hospital
Williamsport, Pennsylvania 17754
United StatesActive - Recruiting
UPMC Memorial
York, Pennsylvania 17408
United StatesActive - Recruiting
Medical University of South Carolina
Charleston, South Carolina 29425
United StatesActive - Recruiting
Sanford Cancer Center Oncology Clinic
Sioux Falls, South Dakota 57104
United StatesActive - Recruiting
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota 57117-5134
United StatesActive - Recruiting
Vanderbilt University/Ingram Cancer Center
Nashville, Tennessee 37232
United StatesActive - Recruiting
Dartmouth Cancer Center - North
Saint Johnsbury, Vermont 05819
United StatesActive - Recruiting
Norris Cotton Cancer Center-North
Saint Johnsbury, Vermont 05819
United StatesActive - Recruiting
Fred Hutchinson Cancer Center
Seattle, Washington 98109
United StatesActive - Recruiting
Marshfield Medical Center-EC Cancer Center
Eau Claire, Wisconsin 54701
United StatesActive - Recruiting
Marshfield Medical Center-Marshfield
Marshfield, Wisconsin 54449
United StatesActive - Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United StatesActive - Recruiting
Marshfield Medical Center - Minocqua
Minocqua, Wisconsin 54548
United StatesActive - Recruiting
ProHealth D N Greenwald Center
Mukwonago, Wisconsin 53149
United StatesActive - Recruiting
ProHealth Oconomowoc Memorial Hospital
Oconomowoc, Wisconsin 53066
United StatesActive - Recruiting
Marshfield Medical Center-River Region at Stevens Point
Stevens Point, Wisconsin 54482
United StatesActive - Recruiting
UW Cancer Center at ProHealth Care
Waukesha, Wisconsin 53188
United StatesActive - Recruiting
Marshfield Medical Center - Weston
Weston, Wisconsin 54476
United StatesActive - Recruiting
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