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Breast NeoplasmsPhase 2NCT06974604

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

A Phase 2 study testing Dexamethasone oral in people with Breast Neoplasms and Lung Neoplasms, run by Brown University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Neoplasms, Lung Neoplasms
What is being tested?
Dexamethasone oral
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
22 Oct 2025to 31 May 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Has advanced and/or metastatic cancer that meets one of the following criteria:
  • Pathologically documented unresectable advanced non-squamous NSCLC not amenable to curative therapy that has progressed on at least one prior therapy.
  • 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
  • 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.
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  • 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:
  • Platelet count ≥100,000/mm3
  • Hemoglobin ≥9.0 g/dL
  • Absolute neutrophil count ≥1000/mm3
  • Creatinine clearance ≥30 mL/min as calculated using the Cockcroft-Gault equation.
  • 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.
  • Has an adequate treatment washout period prior to Cycle 1, Day 1, defined as appropriately recovering from:
  • Major surgery: ≥2 weeks (or 2 weeks for low-invasive cases [eg, colostomy]).
  • Radiation therapy (curative) and palliative radiation therapy to lung fields: ≥4 weeks; ≥2 weeks (palliative radiation therapy to other areas [ie, limited field and 10 or fewer days or fractions] including whole brain radiotherapy).
  • Hormonal therapy: ≥2 weeks
  • Chemotherapy (including immunotherapy [non-antibody based therapy]), and retinoid therapy: ≥2 weeks or 5 times terminal elimination half-life (T½) of the chemotherapeutic agent (whichever is longer); ≥6 weeks for nitrosoureas or mitomycin C, ≥1 week for tyrosine kinase inhibitors (TKIs)
  • Antibody-based anti-cancer therapy: ≥4 weeks
  • Chloroquine/hydroxychloroquine: >14 days
  • If of reproductive/child-bearing potential, agrees to use a highly effective form of contraception or avoid intercourse throughout treatment and upon completion of the study for at least 7 months for females and 4 months for males after the last dose of study drug. Highly effective methods of birth control include: combined (estrogen and progesterone containing) hormonal contraception by oral or intravaginal route or dermal patches; progesterone-only hormonal contraception associated with inhibition of ovulation given by oral route or by injections or implants; intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; vasectomized partner (with confirmation of surgical success); and complete heterosexual abstinence.
  • Starting at the time of randomization/first dose of study intervention male subjects/participants must not freeze or donate sperm at any time during this study and for at least 4 months after the last dose of Dato-DXd. Preservation of sperm should be considered prior to randomization/first dose of study intervention.
  • Starting at the time of randomization/first dose of study intervention female subjects/participants must not breastfeed or donate, or retrieve for their own use, ova at any time during this study and for at least 7 months after the last dose of Dato-DXd. Preservation of ova should be considered prior to randomization/first dose of study intervention.
  • Is able to provide written informed consent and is willing and able to comply with the protocol. Subject must be fully informed about their illness and the investigational nature of the study protocol (including foreseeable risks and possible toxicities) and must sign and date the Institutional Review Board (IRB)/Independent ethics committee (IEC) approved informed consent form (ICF) (including Health Insurance Portability and Accountability Act authorization [HIPAA], if applicable) before performance of any study- specific procedures or examinations.
  • Willingness to self-report level of oral pain using Visual Analog Scale (VAS) and the Normalcy Diet Scale (NDS) throughout each stomatitis event. (40, 41) At baseline, patient's self-reported oral pain level, using VAS, must be 0 (See Appendix B) and the normalcy diet scale score should ≥ 60 (See Appendix C).
  • Willingness to record oral symptoms in Oral Diary (See Appendix D).
  • Has a life expectancy of ≥3 months.

Who cannot join

  • 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
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  • 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.
  • Clinically severe pulmonary compromise resulting from autoimmune, connective tissue or inflammatory disorders with pulmonary involvement.
  • Has uncontrolled or significant cardiac disease (including MI or unstable angina within the past 6 months, NYHA Class II-IV heart failure, uncontrolled hypertension, uncontrolled or significant arrhythmia).
  • Patients with the following may be enrolled based on the investigator's/treating physician's assessment (documentation must be submitted to BrUOG). -Mean resting corrected QTcF interval > 470 ms.
  • History of QT prolongation associated with other medications that required discontinuation of that medication, or any current concomitant medication known to prolong the QT interval and cause Torsades de Pointes.
  • Congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first-degree relatives.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Brown University Oncology Research Group (BrUOG) contact

401-863-3000

BrUOG@brown.edu

Stephanie Graff, MD contact

401-444-5388

Sgraff1@brownhealth.org

United States1 site, 1 recruiting

  • Rhode Island and the Miriam Hospitals (Brown University Health)

    Providence, Rhode Island, 02903/02906

    BrUOG, 401-863-3000, BrUOG@brown.edu

    Stephanie Graff, MD, 401-444-5388, sgraff1@brownhealth.org

    Recruiting

Other trials in United States

About this study

Official title: 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)

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.

Read the detailed description

See above summary

Being tested
Dexamethasone oral
Keywords
Advanced/metastatic hormone-receptor positive [HR+], estrogen receptor and/or progesterone receptor positive, Advanced/metastatic triple negative breast cancer, Advanced/metastatic non-squamous, non-small cell lung cancer
Medical subject headings
Breast Neoplasms, Lung Neoplasms, Triple Negative Breast Neoplasms, Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Dexamethasone oralDrug

    Also called Datopotamab Deruxtecan (Dato-DXd DS-1062a)

    Dexamethasone 10 mL daily for days 1-5 for each of the first 3 cycles of therapy Datopotamab Deruxtecan 6.0 mg/kg IV on day 1 every 21 days

Study groups in NCT06974604
Study groupRoleWhat they receive
Dexamethasone 10mLExperimentalProphylactic oral dexamethasone
Receives: Drug: Dexamethasone oral

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Lower the incidence of all stomatitis

    Lower the incidence of all stomatitis by 20%

    Measured: Approximately 9 weeks

Secondary outcomes (1)

  1. Clinical benefit

    Clinical benefit rate

    Measured: Approximately 9 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2025
  2. Study start22 Oct 2025
  3. Primary completion31 May 2027 (estimated)
  4. Study completion31 May 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06974604
Sponsor's protocol ID
BrUOG 431
Status last verified
Oct 2025
First submitted
8 May 2025
Last updated
24 Oct 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dexamethasone oral in people with Breast Neoplasms and Lung Neoplasms, run by Brown University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 30 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Brown University Oncology Research Group (BrUOG) (401-863-3000, BrUOG@brown.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lower the incidence of all stomatitis (time frame: Approximately 9 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06974604.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2025.

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