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Preventing Dato-DXd Associated Stomatitis With Dexamethasone Mouthwash, TROPION-DM | Clinical Trials | Clareo Health

RECRUITINGPHASE2

Preventing Dato-DXd Associated Stomatitis With Dexamethasone Mouthwash, TROPION-DM

Prevention of Datopotamab Deruxtecan (TROP-2 Directed ADC) Associated Stomatitis in Patients With HER2-negative Metastatic Breast Cancer or Non-small Cell Lung Cancer Using Dexamethasone Mouthwash: a Single-arm, Phase 2 Trial (TROPION- DM, 2023-ESR-000087)

NCT06974604•Brown University

View on ClinicalTrials.gov

Summary

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.

Detailed Description

See above summary

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.
•Has adequate organ function that would make them an appropriate candidate for Datopotamab deruxtecan therapy as treatment of advanced metastatic cancer as assessed by the treating physician, which shall include results of complete blood count with diﬀerential, and comprehensive metabolic panel within 14 days before Cycle 1, Day 1, deﬁned as:
•1. Platelet count ≥100,000/mm3
+20 more criteria

Exclusion Criteria

•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.
•Has an active or uncontrolled hepatitis B and/or hepatitis C infection
•Is lactating or pregnant as conﬁrmed by pregnancy tests performed within 7 days before enrollment.
+5 more criteria

Locations (1)

Rhode Island and the Miriam Hospitals (Brown University Health)

Providence, Rhode Island, United States

Key Dates

Start Date

October 22, 2025

Primary Completion Date

May 31, 2027

Completion Date

May 31, 2029

Last Updated

October 24, 2025

Enrollment

ESTIMATED participants

Conditions

Breast NeoplasmsLung Neoplasms

Interventions

Dexamethasone oral

DRUG

Contacts

Brown University Oncology Research Group (BrUOG)

CONTACT

401-863-3000 BrUOG@brown.edu

Stephanie Graff, MD

CONTACT

401-444-5388 Sgraff1@brownhealth.org

ML Score Prediction of Cardiotoxicity in Cancer Patients Receiving Anthracycline Chemotherapy or HER2-Targeted Therapies

NCT07191730

CardiotoxicityHeart Failure+2 more

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Study of Patritumab Deruxtecan Plus Pembrolizumab With Other Anticancer Agents in Participants With High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/HER-2 Negative Breast Cancer (MK-1022-010, HERTHENA-Breast-03)

NCT06797635

Breast NeoplasmsBreast Cancer

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 24, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Preventing Dato-DXd Associated Stomatitis With Dexamethasone Mouthwash, TROPION-DM

Inclusion Criteria

Exclusion Criteria

ML Score Prediction of Cardiotoxicity in Cancer Patients Receiving Anthracycline Chemotherapy or HER2-Targeted Therapies

Study of Patritumab Deruxtecan Plus Pembrolizumab With Other Anticancer Agents in Participants With High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/HER-2 Negative Breast Cancer (MK-1022-010, HERTHENA-Breast-03)

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Evaluation of Clinical Efficacy of Augmented Reality (AR)-Based Breast Cancer Medical Imaging Solution (SKIA-Breast) Localization Method in Breast Cancer Patients

LUNG-ROLL: Treatment Patterns and Cost of Illness of Lung Cancer in Canada

Anti-Mesothelin TNaive/SCM hYP218 (TNhYP218) CAR T Cells in Participants With Mesothelin-Expressing Solid Tumors Including Mesothelioma