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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: Recruiting Phase 2 study of Breast Neoplasms and Lung Neoplasms, sponsored by Brown University.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Lower the incidence of all stomatitis by 20%
Conditions Studied
Interventions
- DRUG Dexamethasone oral
Study Locations (1)
Rhode Island
- Rhode Island and the Miriam Hospitals (Brown University Health) - Providence
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2025-10-22 |
| Est. Completion | 2029-05-31 |
| Phase | Phase 2 |
What NCT06974604 shows while recruiting
NCT06974604 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 568-participant average among 97 other Breast Neoplasms trials with a reported enrollment target (89% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Breast Neoplasms
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06974604's enrollment target sits among peer trials
60 71st of 97 higher than 26 of 97 other Breast Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Neoplasms trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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