Actively Recruiting
Preventing Dato-DXd Associated Stomatitis With Dexamethasone Mouthwash, TROPION-DM
Led by Brown University · Updated on 2025-10-24
60
Participants Needed
1
Research Sites
188 weeks
Total Duration
On this page
Sponsors
B
Brown University
Lead Sponsor
R
Rhode Island Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Preventing Dato-DXd Associated Stomatitis With Dexamethasone Mouthwash, TROPION-DM
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Has advanced/metastatic cancer that is either unresectable non-squamous NSCLC progressed after prior therapy, triple negative breast cancer progressed after at least one therapy or not candidate for standard therapy, or hormone receptor positive breast cancer progressed after hormonal therapy and at least one chemotherapy/antibody therapy
- Aged 18 years or older
- Eastern Cooperative Oncology Group performance status 0-2
- Left ventricular ejection fraction of 50% or higher by echocardiogram or MUGA within 28 days before enrollment
- Measurable disease per RECIST version 1.1
- Adequate organ function shown by blood counts and metabolic panel within 14 days before first treatment including platelet count ≥100,000/mm3, hemoglobin ≥9.0 g/dL, absolute neutrophil count ≥1000/mm3, creatinine clearance ≥30 mL/min, liver enzymes and bilirubin within specified limits
- Appropriate recovery from prior major surgery, radiation, hormonal, chemotherapy, immunotherapy, or antibody treatment according to specified timeframes
- Agreement to use highly effective contraception or abstain from intercourse during treatment and for specified time after last dose if of reproductive potential
- Male participants agree not to freeze or donate sperm during study and for 4 months after last dose
- Female participants agree not to breastfeed or donate/retrieve ova during study and for 7 months after last dose
- Ability to give informed consent and comply with study procedures
- Willing to self-report oral pain and diet during stomatitis events, starting with no oral pain and normal diet score at baseline
- Life expectancy of at least 3 months
You will not qualify if you...
- Active second cancer that could affect study results
- History or current interstitial lung disease or pneumonitis requiring steroids or suspected but not ruled out by imaging
- Clinically significant corneal disease
- History of severe allergic reactions to the study drug or its ingredients or other monoclonal antibodies
- Ongoing radiation-related side effects
- Uncontrolled infection needing intravenous antibiotics, antivirals, or antifungals
- Active uncontrolled HIV, hepatitis B, or hepatitis C infection
- Pregnant or breastfeeding women
- Severe lung problems from autoimmune or inflammatory diseases
- Uncontrolled or significant heart disease including recent heart attack, heart failure, uncontrolled blood pressure or arrhythmia
- History or risk factors for dangerous heart rhythm problems such as long QT syndrome
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Rhode Island and the Miriam Hospitals (Brown University Health)
Providence, Rhode Island, United States, 02903/02906
Actively Recruiting
Research Team
B
Brown University Oncology Research Group (BrUOG)
CONTACT
S
Stephanie Graff, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here