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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

Primary Purpose

Metastatic Salivary Gland Carcinoma, Recurrent Salivary Gland Carcinoma, Stage III Major Salivary Gland Cancer AJCC v8

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Docetaxel
Questionnaire Administration
Trastuzumab
Trastuzumab Emtansine
Sponsored by
NRG Oncology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Salivary Gland Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Pathologically (histologically or cytologically) proven diagnosis of HER2-positive salivary gland cancer (SGC)

    • 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 eligible to be included on the study. Additionally, pathologists may sign out SDCs under 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/commercial next-generation sequencing (NGS) is required. Any one of the following criteria observed in a primary tumor or metastasis would meet the study definition for "HER2-positive":

      • Immunohistochemistry (IHC) (3+) per the College of American Pathologists (CAP) breast cancer guidelines
      • Gene amplification by FISH (HER2/CEP17 ratio >= 2.0)
      • Gene amplification by NGS (fold change > 2)
  • Patients with unresectable disease who are not candidates for curative surgery or radiation OR recurrent OR metastatic disease that is evident on radiologic imaging
  • Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression

    • Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy
  • Measurable or non-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:

    • Computed tomography (CT) or magnetic resonance imaging (MRI) of the neck (diagnostic quality with contrast, unless contraindicated) AND
    • CT scan of the chest (diagnostic quality with contrast, unless contraindicated) AND
    • CT or MRI of the abdomen and pelvis, if clinically indicated (diagnostic quality with contrast, unless contraindicated)
  • Age >= 18
  • Left ventricular ejection fraction (LVEF) >= 50% assessed by echocardiogram or multigated acquisition (MUGA) scan within 30 days prior to registration
  • Absolute neutrophil count (ANC) >= 1,500 cells/mm^3 (within 14 days prior to registration)
  • Platelets >= 100,000 cells/mm^3 (within 14 days prior to registration)
  • Hemoglobin >= 9.0 g/dL (within 14 days prior to registration) (Note: The use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 9.0 g/dL is acceptable.)
  • Serum creatinine =< 1.5 x upper limit of normal (ULN) OR calculated creatinine clearance (CrCl) >= 30 mL/min by the Cockcroft-Gault formula (within 14 days prior to registration)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 1.5 x institutional ULN (within 14 days prior to registration)
  • Known human immunodeficiency virus (HIV) infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial. Testing is not required for entry into protocol
  • For patients with known evidence of chronic hepatitis B virus (HBV) infection, the HBV 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 unless the viral load becomes undetectable on suppressive therapy. Patients who are immune 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 must have been treated and cured. For patients with HCV infection who are currently on treatment, 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 unless the 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 who has 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 childbearing potential (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 is necessary because the treatment in this study may be significantly teratogenic (See Section 9 for definition of highly effective contraception). Women must refrain from donating eggs during this same period
  • Men with partners of childbearing potential must be willing to use a highly effective form of non-hormonal contraception or two effective forms of non-hormonal contraception by the patient and/or partner, and to continue the use of contraception for the duration of study treatment and for at least 7 months after the last dose of study treatment. Male patients whose partners are pregnant should use condoms for the duration of the pregnancy. Men must refrain from donating sperm during this same period
  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
  • The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the U.S., authorization permitting release of personal health information

Exclusion Criteria:

  • Prior systemic therapy for the study cancer in the unresectable or recurrent and/or metastatic disease setting

    • Note: Prior chemotherapy for a different cancer is allowed; prior androgen receptor targeted therapy in any setting is allowed; prior systemic therapy, including HER2-directed therapies given as neoadjuvant therapy, adjuvant therapy, and/or concurrently with radiation is allowed
  • Patients who have had chemotherapy or palliative-intent radiotherapy must have all toxicities related to prior treatment recovered to =< grade 1 prior to registration
  • 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: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification.)
    • Persistent grade 3-4 (CTCAE version 5.0) electrolyte abnormalities that cannot be reversed despite replacement as indicated by repeat testing
    • Patient must not have an active infection requiring IV antibiotics
  • >= grade 3 peripheral neuropathy
  • Interstitial lung disease or pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence 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 biologic composition to ado-trastuzumab emtansine, trastuzumab, and/or docetaxel (or any of their excipients)
  • 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
  • Pregnancy and individuals unwilling to discontinue nursing

Sites / Locations

  • University of Alabama at Birmingham Cancer CenterRecruiting
  • City of Hope Comprehensive Cancer CenterRecruiting
  • City of Hope at Irvine LennarRecruiting
  • Stanford Cancer Institute Palo AltoRecruiting
  • UCHealth University of Colorado HospitalRecruiting
  • UCHealth Highlands Ranch HospitalRecruiting
  • Saint Luke's Cancer Institute - BoiseRecruiting
  • Saint Luke's Cancer Institute - FruitlandRecruiting
  • Saint Luke's Cancer Institute - MeridianRecruiting
  • Saint Luke's Cancer Institute - NampaRecruiting
  • Saint Luke's Cancer Institute - Twin FallsRecruiting
  • Carle at The RiverfrontRecruiting
  • Carle Physician Group-EffinghamRecruiting
  • Carle Physician Group-Mattoon/CharlestonRecruiting
  • Carle Cancer CenterRecruiting
  • McFarland Clinic - AmesRecruiting
  • Mercy Medical Center - Des MoinesRecruiting
  • UPMC Western MarylandRecruiting
  • University of Michigan Comprehensive Cancer CenterRecruiting
  • Wayne State University/Karmanos Cancer InstituteRecruiting
  • Weisberg Cancer Treatment CenterRecruiting
  • Sanford Joe Lueken Cancer CenterRecruiting
  • Mercy HospitalRecruiting
  • Fairview Southdale HospitalRecruiting
  • Abbott-Northwestern HospitalRecruiting
  • Mayo Clinic in RochesterRecruiting
  • Park Nicollet Clinic - Saint Louis ParkRecruiting
  • Regions HospitalRecruiting
  • United HospitalRecruiting
  • Siteman Cancer Center at West County HospitalRecruiting
  • Washington University School of MedicineRecruiting
  • Siteman Cancer Center-South CountyRecruiting
  • Siteman Cancer Center at Christian HospitalRecruiting
  • Siteman Cancer Center at Saint Peters HospitalRecruiting
  • Dartmouth Hitchcock Medical Center/Dartmouth Cancer CenterRecruiting
  • Memorial Sloan Kettering Basking RidgeRecruiting
  • Memorial Sloan Kettering MonmouthRecruiting
  • Memorial Sloan Kettering BergenRecruiting
  • Memorial Sloan Kettering CommackRecruiting
  • Memorial Sloan Kettering WestchesterRecruiting
  • Mount Sinai ChelseaRecruiting
  • Mount Sinai HospitalRecruiting
  • Memorial Sloan Kettering Cancer CenterRecruiting
  • Memorial Sloan Kettering NassauRecruiting
  • Sanford Bismarck Medical CenterRecruiting
  • Sanford Broadway Medical CenterRecruiting
  • Sanford Roger Maris Cancer CenterRecruiting
  • University of Cincinnati Cancer Center-UC Medical CenterRecruiting
  • Ohio State University Comprehensive Cancer CenterRecruiting
  • Trinity's Tony Teramana Cancer CenterRecruiting
  • University of Cincinnati Cancer Center-West ChesterRecruiting
  • Cancer Centers of Southwest Oklahoma ResearchRecruiting
  • University of Oklahoma Health Sciences CenterRecruiting
  • UPMC AltoonaRecruiting
  • UPMC-Heritage Valley Health System BeaverRecruiting
  • UPMC Hillman Cancer Center at Butler Health SystemRecruiting
  • UPMC Camp HillRecruiting
  • Carlisle Regional Cancer CenterRecruiting
  • UPMC Hillman Cancer Center - Passavant - CranberryRecruiting
  • UPMC Hillman Cancer Center ErieRecruiting
  • UPMC Cancer Center at UPMC HorizonRecruiting
  • UPMC Cancer Centers - Arnold Palmer PavilionRecruiting
  • UPMC Pinnacle Cancer Center/Community Osteopathic CampusRecruiting
  • IRMC Cancer CenterRecruiting
  • UPMC-Johnstown/John P. Murtha Regional Cancer CenterRecruiting
  • UPMC Cancer Center at UPMC McKeesportRecruiting
  • UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer PavilionRecruiting
  • UPMC Hillman Cancer Center - MonroevilleRecruiting
  • UPMC Hillman Cancer Center in CoraopolisRecruiting
  • UPMC Hillman Cancer Center - Part of Frick HospitalRecruiting
  • Arnold Palmer Cancer Center Medical Oncology NorwinRecruiting
  • UPMC Cancer Center-Natrona HeightsRecruiting
  • UPMC Hillman Cancer Center - New CastleRecruiting
  • UPMC-Saint MargaretRecruiting
  • UPMC-Mercy HospitalRecruiting
  • University of Pittsburgh Cancer Institute (UPCI)Recruiting
  • UPMC-Passavant HospitalRecruiting
  • UPMC-Saint Clair Hospital Cancer CenterRecruiting
  • UPMC Cancer Center at UPMC NorthwestRecruiting
  • UPMC Cancer Center-UniontownRecruiting
  • UPMC Cancer Center-WashingtonRecruiting
  • Divine Providence HospitalRecruiting
  • UPMC MemorialRecruiting
  • Medical University of South CarolinaRecruiting
  • Sanford Cancer Center Oncology ClinicRecruiting
  • Sanford USD Medical Center - Sioux FallsRecruiting
  • Vanderbilt University/Ingram Cancer CenterRecruiting
  • Norris Cotton Cancer Center-NorthRecruiting
  • Medical College of WisconsinRecruiting
  • ProHealth D N Greenwald CenterRecruiting
  • ProHealth Oconomowoc Memorial HospitalRecruiting
  • UW Cancer Center at ProHealth CareRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm I (docetaxel, trastuzumab)

Arm II (trastuzumab emtansine)

Arm Description

Patients receive docetaxel IV over 60 minutes on day 1 of each cycle. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive trastuzumab IV over 90 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients receive trastuzumab emtansine IV over 90 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Outcomes

Primary Outcome Measures

Progression-Free Survival (PFS)
Kaplan-Meier method will be used to estimate PFS rates. A log-rank test will be used to assess whether T-DM1 shows a signal of better PFS than the control arm. Cox proportional hazards models, including the stratification factors and with/out other key covariates (e.g., Zubrod performance status), will be used to estimate the treatment effect hazard ratio along with 80% and 95% confidence intervals.

Secondary Outcome Measures

Objective Response Rate (ORR)
Overall tumor response in patients will be assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Only randomized patients who have measurable disease present at baseline will be considered evaluable for response. The ORR, defined as the proportion of complete and partial best overall responses (complete response [CR]+partial response [PR]) will be calculated with their respective 80% and 95% confidence intervals (CI) based normal approximations.
Duration Of Response (DOR)
The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). If the number of responders is sufficient, the Kaplan-Meier method will be used to estimate the DOR rates along with median of DOR and 95% CIs.
Overall Survival (OS)
OS rates will be estimated using the Kaplan-Meier method, and between-arms comparison will be performed using a logrank test (0.10 one-sided significance level). Cox proportional hazards models with the stratification factors and with/out other key covariates (e.g., Zubrod performance status) will be used to estimate the treatment effect hazard ratio along with 80% and 95% confidence intervals.
Incidence of Adverse Events
Adverse events (AEs) will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0. Counts of all adverse events (AEs) by grade will be provided by treatment arm. Counts and frequencies will be provided for the worst grade AE experienced by the patient by treatment arm. The proportion of patients with at least one grade 3 or higher AE will be compared between the treatment arms. All comparisons will be tested using a chi-Square test, or Fisher's exact test if cell frequencies are < 5, with a significance level of 0.10. In addition, 80% and 95% confidence intervals will be provided for these proportions.
Treatment Discontinuations Due to AEs
The proportion of treatment discontinuations due to adverse events between arms will be compared using a chi-Square test (two-sided alpha of 0.10). In addition, 80% and 95% confidence intervals will be provided for these proportions. A two-group chi-square test with a 10% two-sided significance level will have 90% power to detect the difference between Arm 2 proportion of 0.15 and Arm 1 proportion of 0.40 (odds ratio of 3.8) when the number of randomized patients in each group is 58. These figures are reasonable based on data from breast cancer trials (40.9% versus [vs.] 7.2% for docetaxel plus trastuzumab [TH] and ado-trastuzumab emtansine [T-DM1] alone).
Patient-Reported Toxicity
Patient-reported adverse events will be assessed using selected PRO-CTCAE.

Full Information

First Posted
June 2, 2022
Last Updated
September 19, 2023
Sponsor
NRG Oncology
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT05408845
Brief 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
Official Title
A Controlled, Randomized Phase II Trial of Docetaxel Plus Trastuzumab Versus Ado-Trastuzumab Emtansine for Recurrent, Metastatic, or Treatment-Naive, Unresectable HER2-Positive Salivary Gland Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 30, 2022 (Actual)
Primary Completion Date
July 31, 2028 (Anticipated)
Study Completion Date
July 31, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NRG Oncology
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This phase II trial tests whether ado-trastuzumab emtansine works to shrink tumors in patients with HER2-positive salivary gland cancer that has come back (recurrent), spread to other places in the body (metastatic), or cannot be removed by surgery (unresectable). Trastuzumab emtansine is a monoclonal antibody, called 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 emtansine may work better compared to usual treatment of chemotherapy with docetaxel and trastuzumab in treating patients with salivary gland cancer.
Detailed Description
PRIMARY OBJECTIVE: I. To determine if trastuzumab emtansine (ado-trastuzumab emtansine [T-DM1]) shows better progression-free survival (PFS) when compared to docetaxel plus trastuzumab (TH) in recurrent and/or metastatic (R/M) HER2-positive salivary gland cancer (SGC) patients who have not previously received HER2 therapy for unresectable or recurrent and/or metastatic disease, as determined by local assessment. SECONDARY OBJECTIVES: I. To compare the overall response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 criteria between arms. II. To compare overall survival (OS) between arms. III. To compare toxicity using Common Terminology Criteria for Adverse Events (CTCAE) v5.0 criteria between arms. IV. To assess patient-reported toxicity, as measured by the patient reported outcome (PRO)-CTCAE, between arms, and explore patient-reported symptomatic adverse events (AEs) for tolerability of each treatment arm as measured by the PRO-CTCAE. EXPLORATORY OBJECTIVES: I. To assess the ORR in patients who receive crossover treatment to T-DM1/TH following disease progression on the TH arm/T-DM1 arm. II. To collect blood and tissue specimens for future translational science studies to examine how tumor genetics, HER2 signaling output/expression, and HER2 tumoral heterogeneity impact TH and T-DM1 efficacy. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive docetaxel intravenously (IV) over 60 minutes on day 1 of each cycle. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive trastuzumab IV over 90 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive trastuzumab emtansine IV over 90 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Salivary Gland Carcinoma, Recurrent Salivary Gland Carcinoma, Stage III Major Salivary Gland Cancer AJCC v8, Stage IV Major Salivary Gland Cancer AJCC v8, Unresectable Salivary Gland Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
116 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm I (docetaxel, trastuzumab)
Arm Type
Active Comparator
Arm Description
Patients receive docetaxel IV over 60 minutes on day 1 of each cycle. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive trastuzumab IV over 90 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Arm Title
Arm II (trastuzumab emtansine)
Arm Type
Experimental
Arm Description
Patients receive trastuzumab emtansine IV over 90 minutes on day 1 of each cycle. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Other Intervention Name(s)
Docecad, RP56976, Taxotere, Taxotere Injection Concentrate
Intervention Description
Given IV
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Intervention Type
Biological
Intervention Name(s)
Trastuzumab
Other Intervention Name(s)
ABP 980, ALT02, Anti-c-ERB-2, Anti-c-erbB2 Monoclonal Antibody, Anti-ERB-2, Anti-erbB-2, Anti-erbB2 Monoclonal Antibody, Anti-HER2/c-erbB2 Monoclonal Antibody, Anti-p185-HER2, c-erb-2 Monoclonal Antibody, HER2 Monoclonal Antibody, Herceptin, Herceptin Biosimilar PF-05280014, Herceptin Trastuzumab Biosimilar PF-05280014, Herzuma, Kanjinti, MoAb HER2, Monoclonal Antibody c-erb-2, Monoclonal Antibody HER2, Ogivri, Ontruzant, PF-05280014, rhuMAb HER2, RO0452317, SB3, Trastuzumab Biosimilar ABP 980, Trastuzumab Biosimilar ALT02, trastuzumab biosimilar EG12014, Trastuzumab Biosimilar HLX02, Trastuzumab Biosimilar PF-05280014, Trastuzumab Biosimilar SB3, Trastuzumab Biosimilar SIBP-01, Trastuzumab-anns, Trastuzumab-dkst, Trastuzumab-dttb, Trastuzumab-pkrb, Trastuzumab-qyyp, Trazimera
Intervention Description
Given IV
Intervention Type
Biological
Intervention Name(s)
Trastuzumab Emtansine
Other Intervention Name(s)
Ado Trastuzumab Emtansine, ADO-Trastuzumab Emtansine, Kadcyla, PRO132365, RO5304020, T-DM1, Trastuzumab-DM1, Trastuzumab-MCC-DM1, Trastuzumab-MCC-DM1 Antibody-Drug Conjugate, Trastuzumab-MCC-DM1 Immunoconjugate
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Progression-Free Survival (PFS)
Description
Kaplan-Meier method will be used to estimate PFS rates. A log-rank test will be used to assess whether T-DM1 shows a signal of better PFS than the control arm. Cox proportional hazards models, including the stratification factors and with/out other key covariates (e.g., Zubrod performance status), will be used to estimate the treatment effect hazard ratio along with 80% and 95% confidence intervals.
Time Frame
From randomization to disease progression or death due to any cause, whichever occurs first. Analysis occurs after 98 PFS events have been reported, assessed up to 5 years
Secondary Outcome Measure Information:
Title
Objective Response Rate (ORR)
Description
Overall tumor response in patients will be assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Only randomized patients who have measurable disease present at baseline will be considered evaluable for response. The ORR, defined as the proportion of complete and partial best overall responses (complete response [CR]+partial response [PR]) will be calculated with their respective 80% and 95% confidence intervals (CI) based normal approximations.
Time Frame
From randomization to disease progression or last follow-up, assessed up to 5 years
Title
Duration Of Response (DOR)
Description
The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). If the number of responders is sufficient, the Kaplan-Meier method will be used to estimate the DOR rates along with median of DOR and 95% CIs.
Time Frame
From randomization to disease progression or last follow-up, assessed up to 5 years
Title
Overall Survival (OS)
Description
OS rates will be estimated using the Kaplan-Meier method, and between-arms comparison will be performed using a logrank test (0.10 one-sided significance level). Cox proportional hazards models with the stratification factors and with/out other key covariates (e.g., Zubrod performance status) will be used to estimate the treatment effect hazard ratio along with 80% and 95% confidence intervals.
Time Frame
From randomization until death due to any cause or last follow-up, assessed up to 5 years
Title
Incidence of Adverse Events
Description
Adverse events (AEs) will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0. Counts of all adverse events (AEs) by grade will be provided by treatment arm. Counts and frequencies will be provided for the worst grade AE experienced by the patient by treatment arm. The proportion of patients with at least one grade 3 or higher AE will be compared between the treatment arms. All comparisons will be tested using a chi-Square test, or Fisher's exact test if cell frequencies are < 5, with a significance level of 0.10. In addition, 80% and 95% confidence intervals will be provided for these proportions.
Time Frame
From start of treatment to last follow-up, assessed up to 5 years
Title
Treatment Discontinuations Due to AEs
Description
The proportion of treatment discontinuations due to adverse events between arms will be compared using a chi-Square test (two-sided alpha of 0.10). In addition, 80% and 95% confidence intervals will be provided for these proportions. A two-group chi-square test with a 10% two-sided significance level will have 90% power to detect the difference between Arm 2 proportion of 0.15 and Arm 1 proportion of 0.40 (odds ratio of 3.8) when the number of randomized patients in each group is 58. These figures are reasonable based on data from breast cancer trials (40.9% versus [vs.] 7.2% for docetaxel plus trastuzumab [TH] and ado-trastuzumab emtansine [T-DM1] alone).
Time Frame
From start of treatment to end of treatment
Title
Patient-Reported Toxicity
Description
Patient-reported adverse events will be assessed using selected PRO-CTCAE.
Time Frame
From randomization to 12 months
Other Pre-specified Outcome Measures:
Title
Objective Response Rate (ORR) for patients who receive crossover treatment to T-DM1/TH following disease progression on the TH/T-DM1 arm
Description
Overall tumor response will be assessed by RECIST v1.1 (see Section 13). The ORR, defined as the proportion of complete and partial responses (CR+PR) for patients who crossover after disease progression from T-DM1 (TH) to TH (T-DM1) will be calculated with their respective 80% and 95% CIs.
Time Frame
From start of crossover treatment to disease progression, assessed up to 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Pathologically (histologically or cytologically) proven diagnosis of HER2-positive salivary gland cancer (SGC) 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 eligible to be included on the study. Additionally, pathologists may sign out SDCs under 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/commercial next-generation sequencing (NGS) is required. Any one of the following criteria observed in a primary tumor or metastasis would meet the study definition for "HER2-positive": Immunohistochemistry (IHC) (3+) per the College of American Pathologists (CAP) breast cancer guidelines Gene amplification by FISH (HER2/CEP17 ratio >= 2.0) Gene amplification by NGS (fold change > 2) Patients with unresectable disease who are not candidates for curative surgery or radiation OR recurrent OR metastatic disease that is evident on radiologic imaging Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy Measurable or non-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: Computed tomography (CT) or magnetic resonance imaging (MRI) of the neck (diagnostic quality with contrast, unless contraindicated) AND CT scan of the chest (diagnostic quality with contrast, unless contraindicated) AND CT or MRI of the abdomen and pelvis, if clinically indicated (diagnostic quality with contrast, unless contraindicated) Age >= 18 Left ventricular ejection fraction (LVEF) >= 50% assessed by echocardiogram or multigated acquisition (MUGA) scan within 30 days prior to registration Absolute neutrophil count (ANC) >= 1,500 cells/mm^3 (within 14 days prior to registration) Platelets >= 100,000 cells/mm^3 (within 14 days prior to registration) Hemoglobin >= 9.0 g/dL (within 14 days prior to registration) (Note: The use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 9.0 g/dL is acceptable.) Serum creatinine =< 1.5 x upper limit of normal (ULN) OR calculated creatinine clearance (CrCl) >= 30 mL/min by the Cockcroft-Gault formula (within 14 days prior to registration) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 1.5 x institutional ULN (within 14 days prior to registration) Known human immunodeficiency virus (HIV) infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration are eligible for this trial. Testing is not required for entry into protocol For patients with known evidence of chronic hepatitis B virus (HBV) infection, the HBV 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 unless the viral load becomes undetectable on suppressive therapy. Patients who are immune 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 must have been treated and cured. For patients with HCV infection who are currently on treatment, 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 unless the 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 who has 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 childbearing potential (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 is necessary because the treatment in this study may be significantly teratogenic (See Section 9 for definition of highly effective contraception). Women must refrain from donating eggs during this same period Men with partners of childbearing potential must be willing to use a highly effective form of non-hormonal contraception or two effective forms of non-hormonal contraception by the patient and/or partner, and to continue the use of contraception for the duration of study treatment and for at least 7 months after the last dose of study treatment. Male patients whose partners are pregnant should use condoms for the duration of the pregnancy. Men must refrain from donating sperm during this same period Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the U.S., authorization permitting release of personal health information Exclusion Criteria: Prior systemic therapy for the study cancer in the unresectable or recurrent and/or metastatic disease setting Note: Prior chemotherapy for a different cancer is allowed; prior androgen receptor targeted therapy in any setting is allowed; prior systemic therapy, including HER2-directed therapies given as neoadjuvant therapy, adjuvant therapy, and/or concurrently with radiation is allowed Patients who have had chemotherapy or palliative-intent radiotherapy must have all toxicities related to prior treatment recovered to =< grade 1 prior to registration 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: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification.) Persistent grade 3-4 (CTCAE version 5.0) electrolyte abnormalities that cannot be reversed despite replacement as indicated by repeat testing Patient must not have an active infection requiring IV antibiotics >= grade 3 peripheral neuropathy Interstitial lung disease or pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence 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 biologic composition to ado-trastuzumab emtansine, trastuzumab, and/or docetaxel (or any of their excipients) 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 Pregnancy and individuals unwilling to discontinue nursing
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan L Ho
Organizational Affiliation
NRG Oncology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham Cancer Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
205-934-0220
Email
tmyrick@uab.edu
First Name & Middle Initial & Last Name & Degree
Andrew Fuson
Facility Name
City of Hope Comprehensive Cancer Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-826-4673
Email
becomingapatient@coh.org
First Name & Middle Initial & Last Name & Degree
Victoria M. Villaflor
Facility Name
City of Hope at Irvine Lennar
City
Irvine
State/Province
California
ZIP/Postal Code
92618
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
877-467-3411
First Name & Middle Initial & Last Name & Degree
Victoria M. Villaflor
Facility Name
Stanford Cancer Institute Palo Alto
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
650-498-7061
Email
ccto-office@stanford.edu
First Name & Middle Initial & Last Name & Degree
Alexander D. Colevas
Facility Name
UCHealth University of Colorado Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
720-848-0650
First Name & Middle Initial & Last Name & Degree
Daniel W. Bowles
Facility Name
UCHealth Highlands Ranch Hospital
City
Highlands Ranch
State/Province
Colorado
ZIP/Postal Code
80129
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
720-848-0650
First Name & Middle Initial & Last Name & Degree
Daniel W. Bowles
Facility Name
Saint Luke's Cancer Institute - Boise
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
208-381-2774
Email
eslinget@slhs.org
First Name & Middle Initial & Last Name & Degree
Nitya Alluri
Facility Name
Saint Luke's Cancer Institute - Fruitland
City
Fruitland
State/Province
Idaho
ZIP/Postal Code
83619
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
208-381-2774
Email
eslinget@slhs.org
First Name & Middle Initial & Last Name & Degree
Nitya Alluri
Facility Name
Saint Luke's Cancer Institute - Meridian
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
208-381-2774
Email
eslinget@slhs.org
First Name & Middle Initial & Last Name & Degree
Nitya Alluri
Facility Name
Saint Luke's Cancer Institute - Nampa
City
Nampa
State/Province
Idaho
ZIP/Postal Code
83686
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
208-381-2774
Email
eslinget@slhs.org
First Name & Middle Initial & Last Name & Degree
Nitya Alluri
Facility Name
Saint Luke's Cancer Institute - Twin Falls
City
Twin Falls
State/Province
Idaho
ZIP/Postal Code
83301
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
208-381-2774
Email
eslinget@slhs.org
First Name & Middle Initial & Last Name & Degree
Nitya Alluri
Facility Name
Carle at The Riverfront
City
Danville
State/Province
Illinois
ZIP/Postal Code
61832
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-446-5532
Email
Research@Carle.com
First Name & Middle Initial & Last Name & Degree
Prem Sobti
Facility Name
Carle Physician Group-Effingham
City
Effingham
State/Province
Illinois
ZIP/Postal Code
62401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-446-5532
Email
Research@carle.com
First Name & Middle Initial & Last Name & Degree
Prem Sobti
Facility Name
Carle Physician Group-Mattoon/Charleston
City
Mattoon
State/Province
Illinois
ZIP/Postal Code
61938
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-446-5532
Email
Research@carle.com
First Name & Middle Initial & Last Name & Degree
Prem Sobti
Facility Name
Carle Cancer Center
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-446-5532
Email
Research@carle.com
First Name & Middle Initial & Last Name & Degree
Prem Sobti
Facility Name
McFarland Clinic - Ames
City
Ames
State/Province
Iowa
ZIP/Postal Code
50010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
515-239-4734
Email
ksoder@mcfarlandclinic.com
First Name & Middle Initial & Last Name & Degree
Joseph J. Merchant
Facility Name
Mercy Medical Center - Des Moines
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
515-358-6613
Email
cancerresearch@mercydesmoines.org
First Name & Middle Initial & Last Name & Degree
Richard L. Deming
Facility Name
UPMC Western Maryland
City
Cumberland
State/Province
Maryland
ZIP/Postal Code
21502
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
240-964-1400
First Name & Middle Initial & Last Name & Degree
Dan P. Zandberg
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-865-1125
First Name & Middle Initial & Last Name & Degree
Paul L. Swiecicki
Facility Name
Wayne State University/Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
313-576-9790
Email
ctoadmin@karmanos.org
First Name & Middle Initial & Last Name & Degree
Ammar Sukari
Facility Name
Weisberg Cancer Treatment Center
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48334
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
313-576-9790
Email
ctoadmin@karmanos.org
First Name & Middle Initial & Last Name & Degree
Ammar Sukari
Facility Name
Sanford Joe Lueken Cancer Center
City
Bemidji
State/Province
Minnesota
ZIP/Postal Code
56601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
218-333-5000
Email
OncologyClinicalTrialsFargo@sanfordhealth.org
First Name & Middle Initial & Last Name & Degree
Daniel Almquist
Facility Name
Mercy Hospital
City
Coon Rapids
State/Province
Minnesota
ZIP/Postal Code
55433
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
952-993-1517
Email
mmcorc@healthpartners.com
First Name & Middle Initial & Last Name & Degree
Yan Ji
Facility Name
Fairview Southdale Hospital
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
952-993-1517
Email
mmcorc@healthpartners.com
First Name & Middle Initial & Last Name & Degree
Yan Ji
Facility Name
Abbott-Northwestern Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
952-993-1517
Email
mmcorc@healthpartners.com
First Name & Middle Initial & Last Name & Degree
Yan Ji
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
855-776-0015
First Name & Middle Initial & Last Name & Degree
Katharine A. Price
Facility Name
Park Nicollet Clinic - Saint Louis Park
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
952-993-1517
Email
mmcorc@healthpartners.com
First Name & Middle Initial & Last Name & Degree
Yan Ji
Facility Name
Regions Hospital
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
952-993-1517
Email
mmcorc@healthpartners.com
First Name & Middle Initial & Last Name & Degree
Yan Ji
Facility Name
United Hospital
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
952-993-1517
Email
mmcorc@healthpartners.com
First Name & Middle Initial & Last Name & Degree
Yan Ji
Facility Name
Siteman Cancer Center at West County Hospital
City
Creve Coeur
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-600-3606
Email
info@siteman.wustl.edu
First Name & Middle Initial & Last Name & Degree
Douglas R. Adkins
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-600-3606
Email
info@siteman.wustl.edu
First Name & Middle Initial & Last Name & Degree
Douglas R. Adkins
Facility Name
Siteman Cancer Center-South County
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63129
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-600-3606
Email
info@siteman.wustl.edu
First Name & Middle Initial & Last Name & Degree
Douglas R. Adkins
Facility Name
Siteman Cancer Center at Christian Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-600-3606
Email
info@siteman.wustl.edu
First Name & Middle Initial & Last Name & Degree
Douglas R. Adkins
Facility Name
Siteman Cancer Center at Saint Peters Hospital
City
Saint Peters
State/Province
Missouri
ZIP/Postal Code
63376
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-600-3606
Email
info@siteman.wustl.edu
First Name & Middle Initial & Last Name & Degree
Douglas R. Adkins
Facility Name
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-639-6918
Email
cancer.research.nurse@dartmouth.edu
First Name & Middle Initial & Last Name & Degree
Garrett T. Wasp
Facility Name
Memorial Sloan Kettering Basking Ridge
City
Basking Ridge
State/Province
New Jersey
ZIP/Postal Code
07920
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
212-639-7592
First Name & Middle Initial & Last Name & Degree
Alan L. Ho
Facility Name
Memorial Sloan Kettering Monmouth
City
Middletown
State/Province
New Jersey
ZIP/Postal Code
07748
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
212-639-7592
First Name & Middle Initial & Last Name & Degree
Alan L. Ho
Facility Name
Memorial Sloan Kettering Bergen
City
Montvale
State/Province
New Jersey
ZIP/Postal Code
07645
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
212-639-7592
First Name & Middle Initial & Last Name & Degree
Alan L. Ho
Facility Name
Memorial Sloan Kettering Commack
City
Commack
State/Province
New York
ZIP/Postal Code
11725
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
212-639-7592
First Name & Middle Initial & Last Name & Degree
Alan L. Ho
Facility Name
Memorial Sloan Kettering Westchester
City
Harrison
State/Province
New York
ZIP/Postal Code
10604
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
212-639-7592
First Name & Middle Initial & Last Name & Degree
Alan L. Ho
Facility Name
Mount Sinai Chelsea
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
212-824-7309
Email
CCTO@mssm.edu
First Name & Middle Initial & Last Name & Degree
Marshall R. Posner
Facility Name
Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
212-824-7309
Email
CCTO@mssm.edu
First Name & Middle Initial & Last Name & Degree
Marshall R. Posner
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
212-639-7592
First Name & Middle Initial & Last Name & Degree
Alan L. Ho
Facility Name
Memorial Sloan Kettering Nassau
City
Uniondale
State/Province
New York
ZIP/Postal Code
11553
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
212-639-7592
First Name & Middle Initial & Last Name & Degree
Alan L. Ho
Facility Name
Sanford Bismarck Medical Center
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
701-323-5760
Email
OncologyClinicalTrialsFargo@sanfordhealth.org
First Name & Middle Initial & Last Name & Degree
Daniel Almquist
Facility Name
Sanford Broadway Medical Center
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
701-323-5760
Email
OncologyClinicalTrialsFargo@sanfordhealth.org
First Name & Middle Initial & Last Name & Degree
Daniel Almquist
Facility Name
Sanford Roger Maris Cancer Center
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
701-234-6161
Email
OncologyClinicalTrialsFargo@sanfordhealth.org
First Name & Middle Initial & Last Name & Degree
Daniel Almquist
Facility Name
University of Cincinnati Cancer Center-UC Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
513-584-7698
Email
cancer@uchealth.com
First Name & Middle Initial & Last Name & Degree
Christopher Lemmon
Facility Name
Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-293-5066
Email
Jamesline@osumc.edu
First Name & Middle Initial & Last Name & Degree
Marcelo R. Bonomi
Facility Name
Trinity's Tony Teramana Cancer Center
City
Steubenville
State/Province
Ohio
ZIP/Postal Code
43952
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
888-874-7000
First Name & Middle Initial & Last Name & Degree
Dan P. Zandberg
Facility Name
University of Cincinnati Cancer Center-West Chester
City
West Chester
State/Province
Ohio
ZIP/Postal Code
45069
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
513-584-7698
Email
cancer@uchealth.com
First Name & Middle Initial & Last Name & Degree
Christopher Lemmon
Facility Name
Cancer Centers of Southwest Oklahoma Research
City
Lawton
State/Province
Oklahoma
ZIP/Postal Code
73505
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
877-231-4440
First Name & Middle Initial & Last Name & Degree
Minh Phan
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
405-271-8777
Email
ou-clinical-trials@ouhsc.edu
First Name & Middle Initial & Last Name & Degree
Minh Phan
Facility Name
UPMC Altoona
City
Altoona
State/Province
Pennsylvania
ZIP/Postal Code
16601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
412-339-5294
Email
Roster@nrgoncology.org
First Name & Middle Initial & Last Name & Degree
Dan P. Zandberg
Facility Name
UPMC-Heritage Valley Health System Beaver
City
Beaver
State/Province
Pennsylvania
ZIP/Postal Code
15009
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
412-389-5208
Email
haneydl@upmc.edu
First Name & Middle Initial & Last Name & Degree
Dan P. Zandberg
Facility Name
UPMC Hillman Cancer Center at Butler Health System
City
Butler
State/Province
Pennsylvania
ZIP/Postal Code
16001
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
412-389-5208
Email
haneydl@upmc.edu
First Name & Middle Initial & Last Name & Degree
Dan P. Zandberg
Facility Name
UPMC Camp Hill
City
Camp Hill
State/Province
Pennsylvania
ZIP/Postal Code
17011
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
717-975-8900
First Name & Middle Initial & Last Name & Degree
Dan P. Zandberg
Facility Name
Carlisle Regional Cancer Center
City
Carlisle
State/Province
Pennsylvania
ZIP/Postal Code
17015
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
412-339-5294
Email
Roster@nrgoncology.org
First Name & Middle Initial & Last Name & Degree
Dan P. Zandberg
Facility Name
UPMC Hillman Cancer Center - Passavant - Cranberry
City
Cranberry Township
State/Province
Pennsylvania
ZIP/Postal Code
16066
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
412-389-5208
Email
haneydl@upmc.edu
First Name & Middle Initial & Last Name & Degree
Dan P. Zandberg
Facility Name
UPMC Hillman Cancer Center Erie
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16505
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
412-389-5208
Email
haneydl@upmc.edu
First Name & Middle Initial & Last Name & Degree
Dan P. Zandberg
Facility Name
UPMC Cancer Center at UPMC Horizon
City
Farrell
State/Province
Pennsylvania
ZIP/Postal Code
16121
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
412-339-5294
Email
Roster@nrgoncology.org
First Name & Middle Initial & Last Name & Degree
Dan P. Zandberg
Facility Name
UPMC Cancer Centers - Arnold Palmer Pavilion
City
Greensburg
State/Province
Pennsylvania
ZIP/Postal Code
15601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
724-838-1900
First Name & Middle Initial & Last Name & Degree
Dan P. Zandberg
Facility Name
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
717-724-6765
Email
klitchfield@PINNACLEHEALTH.org
First Name & Middle Initial & Last Name & Degree
Dan P. Zandberg
Facility Name
IRMC Cancer Center
City
Indiana
State/Province
Pennsylvania
ZIP/Postal Code
15701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
412-389-5208
Email
haneydl@upmc.edu
First Name & Middle Initial & Last Name & Degree
Dan P. Zandberg
Facility Name
UPMC-Johnstown/John P. Murtha Regional Cancer Center
City
Johnstown
State/Province
Pennsylvania
ZIP/Postal Code
15901
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
814-534-4724
First Name & Middle Initial & Last Name & Degree
Dan P. Zandberg
Facility Name
UPMC Cancer Center at UPMC McKeesport
City
McKeesport
State/Province
Pennsylvania
ZIP/Postal Code
15132
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
412-647-8073
First Name & Middle Initial & Last Name & Degree
Dan P. Zandberg
Facility Name
UPMC Hillman Cancer Center at Rocco And Nancy Ortenzio Cancer Pavilion
City
Mechanicsburg
State/Province
Pennsylvania
ZIP/Postal Code
17050
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
412-389-5208
Email
haneydl@upmc.edu
First Name & Middle Initial & Last Name & Degree
Dan P. Zandberg
Facility Name
UPMC Hillman Cancer Center - Monroeville
City
Monroeville
State/Province
Pennsylvania
ZIP/Postal Code
15146
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
412-389-5208
Email
haneydl@upmc.edu
First Name & Middle Initial & Last Name & Degree
Dan P. Zandberg
Facility Name
UPMC Hillman Cancer Center in Coraopolis
City
Moon
State/Province
Pennsylvania
ZIP/Postal Code
15108
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
412-389-5208
Email
haneydl@upmc.edu
First Name & Middle Initial & Last Name & Degree
Dan P. Zandberg
Facility Name
UPMC Hillman Cancer Center - Part of Frick Hospital
City
Mount Pleasant
State/Province
Pennsylvania
ZIP/Postal Code
15666
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
412-389-5208
Email
haneydl@upmc.edu
First Name & Middle Initial & Last Name & Degree
Dan P. Zandberg
Facility Name
Arnold Palmer Cancer Center Medical Oncology Norwin
City
N. Huntingdon
State/Province
Pennsylvania
ZIP/Postal Code
15642
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
412-389-5208
Email
haneydl@upmc.edu
First Name & Middle Initial & Last Name & Degree
Dan P. Zandberg
Facility Name
UPMC Cancer Center-Natrona Heights
City
Natrona Heights
State/Province
Pennsylvania
ZIP/Postal Code
15065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
724-230-3030
First Name & Middle Initial & Last Name & Degree
Dan P. Zandberg
Facility Name
UPMC Hillman Cancer Center - New Castle
City
New Castle
State/Province
Pennsylvania
ZIP/Postal Code
16105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
412-389-5208
Email
haneydl@upmc.edu
First Name & Middle Initial & Last Name & Degree
Dan P. Zandberg
Facility Name
UPMC-Saint Margaret
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
412-784-4900
First Name & Middle Initial & Last Name & Degree
Dan P. Zandberg
Facility Name
UPMC-Mercy Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15219
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-533-8762
First Name & Middle Initial & Last Name & Degree
Dan P. Zandberg
Facility Name
University of Pittsburgh Cancer Institute (UPCI)
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
412-647-8073
First Name & Middle Initial & Last Name & Degree
Dan P. Zandberg
Facility Name
UPMC-Passavant Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15237
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
412-367-6454
First Name & Middle Initial & Last Name & Degree
Dan P. Zandberg
Facility Name
UPMC-Saint Clair Hospital Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15243
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
412-502-3920
First Name & Middle Initial & Last Name & Degree
Dan P. Zandberg
Facility Name
UPMC Cancer Center at UPMC Northwest
City
Seneca
State/Province
Pennsylvania
ZIP/Postal Code
16346
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
814-676-7900
First Name & Middle Initial & Last Name & Degree
Dan P. Zandberg
Facility Name
UPMC Cancer Center-Uniontown
City
Uniontown
State/Province
Pennsylvania
ZIP/Postal Code
15401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
412-339-5294
Email
Roster@nrgoncology.org
First Name & Middle Initial & Last Name & Degree
Dan P. Zandberg
Facility Name
UPMC Cancer Center-Washington
City
Washington
State/Province
Pennsylvania
ZIP/Postal Code
15301
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
412-339-5294
Email
Roster@nrgoncology.org
First Name & Middle Initial & Last Name & Degree
Dan P. Zandberg
Facility Name
Divine Providence Hospital
City
Williamsport
State/Province
Pennsylvania
ZIP/Postal Code
17754
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
412-339-5294
Email
Roster@nrgoncology.org
First Name & Middle Initial & Last Name & Degree
Dan P. Zandberg
Facility Name
UPMC Memorial
City
York
State/Province
Pennsylvania
ZIP/Postal Code
17408
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
717-724-6760
First Name & Middle Initial & Last Name & Degree
Dan P. Zandberg
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
843-792-9321
Email
hcc-clinical-trials@musc.edu
First Name & Middle Initial & Last Name & Degree
John M. Kaczmar
Facility Name
Sanford Cancer Center Oncology Clinic
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
605-312-3320
Email
OncologyClinicTrialsSF@sanfordhealth.org
First Name & Middle Initial & Last Name & Degree
Daniel Almquist
Facility Name
Sanford USD Medical Center - Sioux Falls
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57117-5134
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
605-312-3320
Email
OncologyClinicalTrialsSF@SanfordHealth.org
First Name & Middle Initial & Last Name & Degree
Daniel Almquist
Facility Name
Vanderbilt University/Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-811-8480
First Name & Middle Initial & Last Name & Degree
Jennifer H. Choe
Facility Name
Norris Cotton Cancer Center-North
City
Saint Johnsbury
State/Province
Vermont
ZIP/Postal Code
05819
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
800-639-6918
Email
cancer.research.nurse@hitchcock.org
First Name & Middle Initial & Last Name & Degree
Garrett T. Wasp
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
414-805-3666
First Name & Middle Initial & Last Name & Degree
Stuart J. Wong
Facility Name
ProHealth D N Greenwald Center
City
Mukwonago
State/Province
Wisconsin
ZIP/Postal Code
53149
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Email
research.institute@phci.org
First Name & Middle Initial & Last Name & Degree
Timothy R. Wassenaar
Facility Name
ProHealth Oconomowoc Memorial Hospital
City
Oconomowoc
State/Province
Wisconsin
ZIP/Postal Code
53066
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
262-928-7878
First Name & Middle Initial & Last Name & Degree
Timothy R. Wassenaar
Facility Name
UW Cancer Center at ProHealth Care
City
Waukesha
State/Province
Wisconsin
ZIP/Postal Code
53188
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Public Contact
Phone
262-928-5539
Email
Chanda.miller@phci.org
First Name & Middle Initial & Last Name & Degree
Timothy R. Wassenaar

12. IPD Sharing Statement

Learn more about this trial

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

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