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

Part of paid clinical trials in Providence, Rhode Island.

Sponsor
Brown University
Study ID
NCT06974604
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dexamethasone oral — DRUG
    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

Study Details

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.

Key Dates

Start date
Oct 22, 2025
Status verified
Oct 2025
Primary completion
May 31, 2027
Completion
May 31, 2029

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dexamethasone 10mL
    Prophylactic oral dexamethasone

Primary Outcome Measure

Lower the incidence of all stomatitis [ Time Frame: Approximately 9 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Rhode Island and the Miriam Hospitals (Brown University Health)ProvidenceRhode Island02903/02906
BrUOG
[email protected]
401-863-3000
Stephanie Graff, MD
[email protected]
401-444-5388

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