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Preventing Dato-DXd Associated Stomatitis With Dexamethasone Mouthwash, TROPION-DM

NCT06974604 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-10-24

No results posted yet for this study

Summary

TROPION-DM/BrUOG-431 is a prospective, , phase 2 trial with two non-comparative cohorts analyzed jointly for primary endpoint in adult patients with either (Cohort 1:) advanced/metastatic hormone-receptor positive (\[HR+\], estrogen receptor and/or progesterone receptor positive) breast cancer (BC), or advanced/metastatic triple negative breast cancer (TNBC) or (Cohort 2:) advanced/metastatic non-squamous non-small cell lung cancer (NSCLC).

All patients will be treated with Datopotumab deruxtecan (Dato-DXd) at 6 mg/kg IV every 3 weeks until disease progression or unacceptable toxicity. Due to the risk of stomatitis, the investigational component of this trial will be to incorporate alcohol-free dexamethasone mouthwash, 10 mL 0.5 mg/5mL oral solution, days 1-5, swish and spit four times daily for the first 3 cycles.

Conditions

  • Breast Neoplasms
  • Lung Neoplasms

Interventions

DRUG

Dexamethasone oral

Dexamethasone 10 mL daily for days 1-5 for each of the first 3 cycles of therapy Datopotamab Deruxtecan 6.0 mg/kg IV on day 1 every 21 days

Sponsors & Collaborators

  • Rhode Island Hospital

    collaborator OTHER

  • The Miriam Hospital

    collaborator OTHER

  • Brown University

    lead OTHER

Principal Investigators

  • Stephanie Graff, MD · Rhode Island and the Miriam Hospitals (Brown University Health)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-22
Primary Completion
2027-05-31
Completion
2029-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06974604 on ClinicalTrials.gov