Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06974604 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Aug 31, 2025 to Oct 22, 2025
    • Site details revised
    v5
  2. Start date: Jul 31, 2025 to Aug 31, 2025v4
  3. Start date: May 31, 2025 to Jul 31, 2025v3
  4. Primary endpoint revisedv2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Brown University
80 trials monitored
See 9 trials at risk
Breast Cancer
5,418 trials monitored
See 296 trials at risk
Lung Cancer
4,790 trials monitored
See 263 trials at risk
Non-Small Cell Lung Cancer (NSCLC)
3,078 trials monitored
See 172 trials at risk
and 1 more disease
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.
Trial Details
NCT Number NCT06974604
Lead Sponsor Brown University
Collaborators: Rhode Island Hospital, The Miriam Hospital
Conditions
(from sponsor)		 Breast Neoplasms, Lung Neoplasms
Related terms Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Triple Negative Breast Neoplasms
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov