OncoMatch/Clinical Trials/NCT06974604
Preventing Dato-DXd Associated Stomatitis With Dexamethasone Mouthwash, TROPION-DM
Is NCT06974604 recruiting? Yes, currently enrolling (May 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
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
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