An Open-label, Single-arm Study of Prophylaxis for Datopotamab Deruxtecan (Dato-DXd) -Related Stomatitis in Eligible Patients With Metastatic or Inoperable Locally Recurrent Breast Cancer or Locally Advanced or Metastatic Epidermal Growth Factor Receptor-Mutated Non-small Cell Lung Cancer.
A Phase IV, Open-Label, Single-Arm Study of Prophylaxis for Datopotamab Deruxtecan-related Stomatitis in Eligible Patients With Metastatic or Inoperable Locally Recurrent Breast Cancer or Locally Advanced or Metastatic Epidermal Growth Factor Receptor-Mutated Non-Small Cell Lung Cancer (TROPION-SWISH)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 18 months
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Enrollment of participants is planned to occur over approximately 18 months, with a minimum of 12 weeks of follow-up for each participant after the first Dato-DXd dose."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
This is a multicenter, open-label, single-arm study of prophylaxis for Dato-DXd-related stomatitis in eligible patients with metastatic or inoperable locally recurrent breast cancer or locally advanced or metastatic Epidermal Growth Factor Receptor-Mutated (EGFRm) non-small cell lung cancer
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official eligibility criteria
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.
Study sites (41)
AR
- Research Site · Hot Springs, AR 71913More trials in Hot Springs
- Research Site · Little Rock, AR 72205More trials in Little Rock
AZ
- Research Site · Tucson, AZ 85719More trials in Tucson
CA
- Research Site · Duarte, CA 91010More trials in Duarte
- Research Site · Glendale, CA 91204More trials in Glendale
- Research Site · Lakewood, CA 90805More trials in Lakewood
- Research Site · Long Beach, CA 90806More trials in Long Beach
- Research Site · Torrance, CA 90505More trials in Torrance
DC
- Research Site · Washington D.C., DC 20037More trials in Washington D.C.
FL
- Research Site · Coral Springs, FL 33065More trials in Coral Springs
- Research Site · Plantation, FL 33322More trials in Plantation
GA
- Research Site · Athens, GA 30607More trials in Athens
ID
- Research Site · Boise, ID 83706More trials in Boise
IL
- Research Site · Park Ridge, IL 60068More trials in Park Ridge
IN
- Research Site · Fort Wayne, IN 46825More trials in Fort Wayne
KY
- Research Site · Elizabethtown, KY 42701More trials in Elizabethtown
- Research Site · Lexington, KY 40503More trials in Lexington
- Research Site · Lexington, KY 40509More trials in Lexington
- Research Site · Louisville, KY 40207More trials in Louisville
LA
- Research Site · New Orleans, LA 70112More trials in New Orleans
MD
- Research Site · Frederick, MD 21702More trials in Frederick
- Research Site · Glenn Dale, MD 20769More trials in Glenn Dale
MI
- Research Site · Detroit, MI 48202More trials in Detroit
- Research Site · Grayling, MI 49738More trials in Grayling
MN
- Research Site · Minneapolis, MN 55426More trials in Minneapolis
MO
- Research Site · Kansas City, MO 64111More trials in Kansas City
NC
- Research Site · Greensboro, NC 27403More trials in Greensboro
- Research Site · Wilson, NC 27893More trials in Wilson
NH
- Research Site · Lebanon, NH 03756More trials in Lebanon
NV
- Research Site · Reno, NV 89502More trials in Reno
NY
- Research Site · East Syracuse, NY 13057More trials in East Syracuse
- Research Site · Westbury, NY 11590More trials in Westbury
- Research Site · White Plains, NY 10601More trials in White Plains
OH
- Research Site · Cleveland, OH 44106More trials in Cleveland
PA
- Research Site · Wynnewood, PA 19096More trials in Wynnewood
SC
- Research Site · West Columbia, SC 29169More trials in West Columbia
TN
- Research Site · Knoxville, TN 37920More trials in Knoxville
VA
- Research Site · Fairfax, VA 22031More trials in Fairfax
WI
- Research Site · Waukesha, WI 53188More trials in Waukesha
WV
- Research Site · Charleston, WV 25304More trials in Charleston
- Research Site · Morgantown, WV 26506More trials in Morgantown