Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
RecruitingPhase 2interventionalRules rewrite

Phase 2: testing Docetaxel for Metastatic Salivary Gland Carcinoma

This phase II trial compares the effect of usual treatment of docetaxel chemotherapy plus trastuzumab, to ado-emtansine (T-DM1) in patients with HER2-positive 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.

Official registry: https://clinicaltrials.gov/study/NCT05408845 · NRG Oncology · enrollment listed as 146

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Biopsy Procedure, Biospecimen Collection, or Computed Tomography. The registry lists allocation as randomized. This phase II trial compares the effect of usual treatment of docetaxel chemotherapy plus trastuzumab, to ado-emtansine (T-DM1) in patients with HER2-positive 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).

They plan to enroll about 146 people at 154 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic, a procedure as part of the study plus check-ins.

Official title (unrewritten)

A Phase II Trial of HER2-Targeted Therapies for Recurrent, Metastatic, or Unresectable HER2-Expressing Salivary Gland Cancers

Interventions: Biopsy Procedure, Biospecimen Collection, Computed Tomography, Docetaxel, Echocardiography Test, Magnetic Resonance Imaging, Multigated Acquisition Scan, Questionnaire Administration, Trastuzumab, Trastuzumab Deruxtecan, Trastuzumab Emtansine

Primary outcome (registry wording): Progression free survival (PFS) (HER2-Positive Cohort)

Who it is for (from inclusion criteria)

  • Ages 18 Years to any
  • Pathologically (histologically or cytologically) proven diagnosis of HER2-positive OR HER2-low expressing recurrent/metastatic salivary gland cancer (SGC)
  • HER2-positive cohort:
  • 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)
  • HER2-low expressing cohort:
  • Note: Local HER2 evaluation by immunohistochemistry (IHC) or fluorescent in-situ hybridization (FISH) is required. Any one of the following criteria observed in a primary tumor or metastasis would meet the study definition for "HER2-low":

Contact

No central phone on the registry card. Use the official listing to reach a site.

Sites listed on ClinicalTrials.gov

154 listed

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FAQ about this NCT record

Is NCT05408845 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT05408845?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT05408845?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary