OncoMatch/Clinical Trials/NCT06974604
Preventing Dato-DXd Associated Stomatitis With Dexamethasone Mouthwash, TROPION-DM
Is NCT06974604 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies Dexamethasone oral for breast neoplasms.
Treatment: Dexamethasone oral — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) negative (negative)
Required: HER2 (ERBB2) negative (negative)
Required: ESR1 negative (negative)
Required: ESR1 positive (positive)
Required: PR (PGR) negative (negative)
Required: PR (PGR) positive (positive)
Disease stage
Required: Stage IV
advanced and/or metastatic cancer...Measurable disease based on Response Evaluation Criteria in Solids Tumors (RECIST) version 1.1.
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received:
progressed on at least one prior therapy
Must have received:
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
Must have received: hormonal therapy
progressed on hormonal based therapy including CDK4/6 inhibitor
Must have received: CDK4/6 inhibitor
progressed on hormonal based therapy including CDK4/6 inhibitor
Must have received:
1 prior line of chemotherapy and/or antibody drug conjugate therapy
Lab requirements
Blood counts
Platelet count ≥100,000/mm3; Hemoglobin ≥9.0 g/dL; Absolute neutrophil count ≥1000/mm3
Kidney function
Creatinine clearance ≥30 mL/min as calculated using the Cockcroft-Gault equation.
Liver function
Aspartate aminotransferase ≤3 ×ULN (if liver metastases are present, ≤5 × ULN); Alanine aminotransferase ≤3 × ULN (if liver metastases are present, ≤5 × ULN); Total bilirubin ≤1.5 × ULN if no liver metastases or liver < 3 if liver metastases are present.
Cardiac function
Left ventricular ejection fraction (LVEF) ≥50% by ECHO or MUGA within 28 days before enrollment.
Has adequate organ function...Platelet count ≥100,000/mm3; Hemoglobin ≥9.0 g/dL; Absolute neutrophil count ≥1000/mm3; Creatinine clearance ≥30 mL/min...Aspartate aminotransferase ≤3 ×ULN (if liver metastases are present, ≤5 × ULN); Alanine aminotransferase ≤3 × ULN (if liver metastases are present, ≤5 × ULN); Total bilirubin ≤1.5 × ULN if no liver metastases or liver < 3 if liver metastases are present. Left ventricular ejection fraction (LVEF) ≥50% by ECHO or MUGA within 28 days before enrollment.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Rhode Island and the Miriam Hospitals (Brown University Health) · Providence, Rhode Island
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06974604 currently recruiting?
Yes, this trial is currently recruiting patients.
Is prior treatment required for enrollment?
Yes. Patients must have previously received and .
Does this trial require ERBB2?
Yes, ERBB2 negative is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 negative is a required biomarker for enrollment.
Does this trial require ESR1?
Yes, ESR1 negative is a required biomarker for enrollment.
What disease stage is eligible?
Stage IV is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
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