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NCT06974604 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Breast Neoplasms and Lung Neoplasms, sponsored by Brown University.

Recruiting
Registry status
Phase 2
Development phase
60
Enrollment target
1
Study location

NCT06974604 is a Phase 2 study of Breast Neoplasms and Lung Neoplasms that is actively recruiting participants, run by Brown University. The registered enrollment target is 60 participants, below the 568-participant average among 97 other Breast Neoplasms trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT06974604, a Phase 2 study of Breast Neoplasms and Lung Neoplasms, is actively recruiting participants, sponsored by Brown University.

RECRUITING
Registry status
Phase 2
Development phase
60 participants
Enrollment target
1
Study location

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 Studied

Breast Neoplasms Lung Neoplasms

Interventions

  • DRUG Dexamethasone oral

Study Locations (1)

Rhode Island

  • Rhode Island and the Miriam Hospitals (Brown University Health) - Providence

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2025-10-22
Est. Completion 2029-05-31
Phase Phase 2

Sponsor

Brown University

231 total trials

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What the Registry Record Tells You About NCT06974604

The ClinicalTrials.gov registry entry for NCT06974604 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 568-participant average among 97 other Breast Neoplasms trials with a reported enrollment target (89% lower). The listed sponsor is Brown University, which has 231 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Breast Neoplasms appearing as the primary indexed condition, and to 1 intervention - of which Dexamethasone oral is the first listed.

NCT06974604 reports 1 study location spanning 1 distinct geographic area - top geographies include Rhode Island.

Frequently Asked Questions

What is clinical trial NCT06974604 about?

NCT06974604 is a clinical study titled "Preventing Dato-DXd Associated Stomatitis With Dexamethasone Mouthwash, TROPION-DM". 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),...

What is the current status of trial NCT06974604?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2025-10-22. Estimated completion is 2029-05-31.

What conditions does trial NCT06974604 study?

This clinical trial studies the following conditions: Breast Neoplasms, Lung Neoplasms.

What interventions are being tested in trial NCT06974604?

The interventions under investigation include: Dexamethasone oral (DRUG).

Who is sponsoring clinical trial NCT06974604?

This trial is sponsored by Brown University, which has 231 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06974604 being conducted?

This trial has 1 study location across Rhode Island. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.