Condition: Breast Neoplasms · Lung Neoplasms · Sponsor: Brown University
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.
This description comes directly from the study's public registry record.
Brown University Oncology Research Group (BrUOG) · 401-863-3000 · BrUOG@brown.edu
Stephanie Graff, MD · 401-444-5388 · Sgraff1@brownhealth.org
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| Rhode Island and the Miriam Hospitals (Brown University Health) | Providence, Rhode Island, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06974604