Preventing Dato-DXd Associated Stomatitis With Dexamethasone Mouthwash, TROPION-DM
Eligible age
18+ yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: Brown University
You may qualify if…
- ✓ Has advanced and/or metastatic cancer that meets one of the following criteria:
- ✓ 1. Pathologically documented unresectable advanced non-squamous NSCLC not amenable to curative therapy that has progressed on at least one prior therapy.
- ✓ 2. Pathologically documented triple negative breast cancer (estrogen receptor negative and progesterone receptor negative and HER2 negative) who have progressed on at least 1 prior line of therapy or in the opinion of the treating physician, not be a candidate for standard first-line metastatic breast cancer therapy
- ✓ 3. Pathologically documented hormone receptor positive breast cancer (estrogen receptor and/or progesterone receptor positive, HER2 negative) which has progressed on hormonal based therapy including CDK4/6 inhibitor and 1 prior line of chemotherapy and/or antibody drug conjugate therapy.
- ✓ Aged ≥18 years.
- ✓ Has an Eastern Cooperative Oncology Group performance status 0-2.
- ✓ Has a left ventricular ejection fraction (LVEF) 50% by either an echocardiogram (ECHO) or multiple gated acquisition scan (MUGA) within 28 days before enrollment.
- ✓ Measurable disease based on Response Evaluation Criteria in Solids Tumors (RECIST) version 1.1.
You may not qualify if…
- ✕ Active second malignancy which would alter interpretation of study results.
- ✕ Has a history of non-infectious ILD/pneumonitis including radiation pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
- ✕ Has clinically significant corneal disease
- ✕ Has a history of severe hypersensitivity reactions to either the drug or inactive ingredients (including but not limited to polysorbate 80) of Dato-DXd.
- ✕ Has a history of severe hypersensitivity reactions to other monoclonal antibodies.
- ✕ Has ongoing radiation-related toxicities
- ✕ Has an uncontrolled infection requiring intravenous (IV) antibiotics, antivirals, or antifungals.
- ✕ Has active human immunodeficiency virus (HIV) infection that is not well controlled.
Where it's recruiting
Providence
Source: ClinicalTrials.gov · NCT06974604 · last updated 2025-10-24