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

NCT06974604

This study is recruiting at 1 US site in 1 state, according to its ClinicalTrials.gov record last updated .

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.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

  • Breast Neoplasms
  • Lung Neoplasms

Eligibility basics and study details

Study type
Interventional
Phase
Phase 2
Ages
18 years and older
Sex
All
Healthy volunteers
Not accepted
Sponsor
Brown University
Last updated on ClinicalTrials.gov
October 24, 2025

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites

Rhode Island · 1

  • Rhode Island and the Miriam Hospitals (Brown University Health) · Providence, RI

Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.