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Mouthwash may stop cancer Drug's painful side effect

NCT ID NCT07357597

Symptom relief Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 5 times

Summary

This study tests if a steroid mouthwash can prevent or reduce mouth sores caused by the cancer drug datopotamab deruxtecan (Dato-DXd). About 100 adults with advanced breast or lung cancer will use the mouthwash and be monitored for 12 weeks. The goal is to see if this simple step can improve quality of life during treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Patients are eligible to be included in the study only if all the following criteria apply: Disease Characteristics 1. Patients with any of the following disease characteristics are eligible (specific population subject to FDA Dato-DXd label): • Patients with unresectable or metastatic HR+/HER2- (IHC 0, IHC 1+, or IHC 2+/ISH-) breast cancer who have received prior ET and chemotherapy for unresectable or metastatic disease. OR • Adult patients with unresectable or metastatic TNBC who are not candidates for PD-1/PD-L1 inhibitor therapy. Participants will be enrolled upon FDA approval on use of Dato-DXd for this indication. OR • Patients with locally advanced or metastatic EGFRm NSCLC who have received prior EGFR-directed therapy and platinum-based chemotherapy. Age 2. Patient must be ≥ 18 years, at the time of signing the informed consent. Type of Patient and Disease Characteristics- 3. Has documentation that Dato-DXd will be prescribed for the labelled indication and has not received any dose of Dato-DXd prior to enrollment. 4. Is willing to comply with use of prophylactic dexamethasone mouthwash at the start of first infusion and throughout Dato-DXd administration. 5. ECOG performance status 0 or 1. 6. Has adequate bone marrow function (hemoglobin ≥ 9 g/dL; red blood cell/plasma transfusion is not allowed within 1 week prior to screening assessment). 7. All women of childbearing potential must have a negative serum pregnancy test result at screening. Informed Consent 8. Capable of giving signed informed consent as described in the protocol which includes compliance with the requirements and restrictions listed in the ICF and the protocol. Exclusion Criteria: Patients are excluded from the study if any of the following criteria apply: 1. Has received Dato-DXd prior to enrollment. Medical Conditions 2. As judged by the investigator, any evidence of cardiac, pulmonary, vascular, and other renal conditions which in the investigator's opinion makes it undesirable for the patient to participate in the study. 3. Has any-grade active and uncontrolled stomatitis or mouth ulcers at baseline (participants with prior medical history of stomatitis or mouth ulcers are eligible). 4. Use of steroid-containing mouthwash is contraindicated in, including but not limited to: * Active oral infections (eg, viral, bacterial, or fungal), where the use of a steroid-containing mouthwash may impair local immune response and delay healing * Known hypersensitivity or allergy to corticosteroids or any excipients contained in the mouthwash formulation 5. Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals; suspected infections (eg, prodromal symptoms); or inability to rule out infections (participants with localized fungal infections of skin or nails are eligible). 6. Has clinically significant corneal disease. 7. Has a history of severe hypersensitivity reactions to either the drug or inactive ingredients of Dato-DXd (including, but not limited to, polysorbate 80). 8. Has a history of severe hypersensitivity reactions to other monoclonal antibodies. 9. Is pregnant, or breastfeeding, or planning to become pregnant. Other Exclusions 10. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site). 11. Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements. 12. Previous enrollment in the present study.

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Conditions

The condition(s) this trial relates to.

breast cancer hormone receptor-positive breast cancer non-small cell lung carcinoma triple-negative breast carcinoma stomatitis prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Stomatitis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    30 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Research Site

    WITHDRAWN

    Tucson, Arizona, 85719, United States

  • Research Site

    RECRUITING

    Hot Springs, Arkansas, 71913, United States

  • Research Site

    RECRUITING

    Little Rock, Arkansas, 72205, United States

  • Research Site

    NOT_YET_RECRUITING

    Duarte, California, 91010, United States

  • Research Site

    RECRUITING

    Glendale, California, 91204, United States

  • Research Site

    RECRUITING

    Lakewood, California, 90805, United States

  • Research Site

    RECRUITING

    Long Beach, California, 90806, United States

  • Research Site

    NOT_YET_RECRUITING

    Torrance, California, 90505, United States

  • Research Site

    WITHDRAWN

    Washington D.C., District of Columbia, 20037, United States

  • Research Site

    NOT_YET_RECRUITING

    Plantation, Florida, 33322, United States

  • Research Site

    RECRUITING

    Athens, Georgia, 30607, United States

  • Research Site

    WITHDRAWN

    Boise, Idaho, 83706, United States

  • Research Site

    WITHDRAWN

    Park Ridge, Illinois, 60068, United States

  • Research Site

    RECRUITING

    Fort Wayne, Indiana, 46825, United States

  • Research Site

    NOT_YET_RECRUITING

    Elizabethtown, Kentucky, 42701, United States

  • Research Site

    NOT_YET_RECRUITING

    Lexington, Kentucky, 40503, United States

  • Research Site

    NOT_YET_RECRUITING

    Lexington, Kentucky, 40509, United States

  • Research Site

    NOT_YET_RECRUITING

    Louisville, Kentucky, 40207, United States

  • Research Site

    NOT_YET_RECRUITING

    New Orleans, Louisiana, 70112, United States

  • Research Site

    WITHDRAWN

    Frederick, Maryland, 21702, United States

  • Research Site

    NOT_YET_RECRUITING

    Glenn Dale, Maryland, 20769, United States

  • Research Site

    NOT_YET_RECRUITING

    Detroit, Michigan, 48202, United States

  • Research Site

    NOT_YET_RECRUITING

    Grayling, Michigan, 49738, United States

  • Research Site

    RECRUITING

    Minneapolis, Minnesota, 55426, United States

  • Research Site

    NOT_YET_RECRUITING

    Kansas City, Missouri, 64111, United States

  • Research Site

    WITHDRAWN

    Reno, Nevada, 89502, United States

  • Research Site

    WITHDRAWN

    Lebanon, New Hampshire, 03756, United States

  • Research Site

    RECRUITING

    East Syracuse, New York, 13057, United States

  • Research Site

    NOT_YET_RECRUITING

    Westbury, New York, 11590, United States

  • Research Site

    WITHDRAWN

    White Plains, New York, 10601, United States

  • Research Site

    NOT_YET_RECRUITING

    Greensboro, North Carolina, 27403, United States

  • Research Site

    RECRUITING

    Wilson, North Carolina, 27893, United States

  • Research Site

    NOT_YET_RECRUITING

    Cleveland, Ohio, 44106, United States

  • Research Site

    RECRUITING

    Wynnewood, Pennsylvania, 19096, United States

  • Research Site

    NOT_YET_RECRUITING

    Knoxville, Tennessee, 37920, United States

  • Research Site

    NOT_YET_RECRUITING

    Fairfax, Virginia, 22031, United States

  • Research Site

    WITHDRAWN

    Charleston, West Virginia, 25304, United States

  • Research Site

    NOT_YET_RECRUITING

    Morgantown, West Virginia, 26506, United States

  • Research Site

    NOT_YET_RECRUITING

    Waukesha, Wisconsin, 53188, United States

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