OncoMatch/Clinical Trials/NCT05408845
Testing the Use of Ado-Trastuzumab Emtansine Compared to the Usual Treatment (Chemotherapy With Docetaxel Plus Trastuzumab) or Trastuzumab Deruxtecan for Recurrent, Metastatic, or Unresectable HER2-Expressing Salivary Gland Cancers
Is NCT05408845 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Trastuzumab and Trastuzumab Deruxtecan for metastatic salivary gland carcinoma.
Treatment: Docetaxel · Trastuzumab · Trastuzumab Deruxtecan · Trastuzumab Emtansine — This phase II trial compares the effect of usual treatment of docetaxel chemotherapy plus trastuzumab, to ado-emtansine (T-DM1) in patients with HER2-postive salivary gland cancer that has come back (recurrent), that has spread from where it first started (primary site) to other places in the body, or cannot be removed by surgery (unresectable). This trial is also testing how well trastuzumab deruxtecan works in treating patients with HER2-low recurrent or metastatic salivary gland cancer. Trastuzumab is a form of targeted therapy because it works by attaching itself to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors. When trastuzumab attaches to HER2 receptors, the signals that tell the cells to grow are blocked and the cancer cell may be marked for destruction by body's immune system. Trastuzumab emtansine contains trastuzumab, linked to a chemotherapy drug called emtansine. Trastuzumab attaches to HER2 positive cancer cells in a targeted way and delivers emtansine to kill them. Trastuzumab deruxtecan is a monoclonal antibody called traztuzumab, linked to a chemotherapy drug called deruxtecan. Trastuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors and delivers deruxtecan to kill them. Docetaxel is in a class of medications called taxanes. It stops cancer cells from growing and dividing and may kill them. Trastuzumab emtansine may work better compared to usual treatment of chemotherapy with docetaxel and trastuzumab or trastuzumab deruxtecan in treating patients with recurrent, metastatic or unresectable salivary gland cancer.
Check if I qualifyExtracted eligibility criteria
Cancer type
Head and Neck Squamous Cell Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) overexpression (IHC 3+ per CAP breast cancer guidelines) (IHC 3+)
Immunohistochemistry (IHC) (3+) per the College of American Pathologists (CAP) breast cancer guidelines
Required: HER2 (ERBB2) amplification by FISH (HER2/CEP17 ratio >= 2.0) (HER2/CEP17 ratio >= 2.0)
Gene amplification by FISH (HER2/CEP17 ratio >= 2.0)
Required: HER2 (ERBB2) amplification by NGS (fold change >= 2) (fold change >= 2)
Gene amplification by NGS (fold change >= 2)
Required: HER2 (ERBB2) low expression (IHC 1+ per CAP breast cancer guidelines) (IHC 1+)
IHC 1+ per the College of American Pathologists (CAP) breast cancer guidelines
Required: HER2 (ERBB2) low expression (IHC 2+ without evidence of amplification by FISH) (IHC 2+ without amplification by FISH)
IHC 2+ without evidence of amplification by FISH
Disease stage
Required: Stage III, IV (AJCC v8)
Stage III Major Salivary Gland Cancer AJCC v8; Stage IV Major Salivary Gland Cancer AJCC v8; Unresectable Salivary Gland Carcinoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: systemic therapy for study cancer in unresectable or recurrent/metastatic setting
Exception: 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
HER2-positive cohort: Prior systemic therapy for the study cancer in the unresectable or recurrent and/or metastatic disease setting
Cannot have received: HER2 directed therapy for unresectable or recurrent or metastatic disease
HER2-low expressing cohort: HER2 directed therapy for unresectable or recurrent or metastatic disease is not allowed
Lab requirements
Blood counts
ANC >= 1,500 cells/mm^3; Platelets >= 100,000 cells/mm^3; Hemoglobin >= 9.0 g/dL
Kidney function
Serum creatinine <= 1.5 x ULN OR calculated creatinine clearance >= 30 mL/min by Cockcroft-Gault formula
Liver function
HER2-positive cohort: Total bilirubin <= 1.5 x ULN; AST and ALT <= 1.5 x ULN. HER2-low expressing cohort: Total bilirubin <= 1.5 x ULN if no liver metastases; < 3 x ULN in presence of Gilbert's Syndrome or liver metastases; AST and ALT <= 3 x ULN if no liver metastases; < 5 x ULN with liver metastases; Serum albumin >= 2.5 g/dL
Cardiac function
Left ventricular ejection fraction (LVEF) >= 50% assessed by echocardiogram or MUGA scan
ANC >= 1,500 cells/mm^3; Platelets >= 100,000 cells/mm^3; Hemoglobin >= 9.0 g/dL; Serum creatinine <= 1.5 x ULN OR CrCl >= 30 mL/min; Total bilirubin, AST, ALT, albumin as above; LVEF >= 50%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Alabama at Birmingham Cancer Center · Birmingham, Alabama
- City of Hope Comprehensive Cancer Center · Duarte, California
- Kaiser Permanente Dublin · Dublin, California
- Kaiser Permanente-Fremont · Fremont, California
- Kaiser Permanente Fresno Orchard Plaza · Fresno, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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