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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)

Status: Recruiting
Location: See all (39) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ Patients are eligible to be included in the study only if all the following criteria apply:

⁃ Disease Characteristics

• 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

• Patient must be ≥ 18 years, at the time of signing the informed consent.

• Type of Patient and Disease Characteristics-

• Has documentation that Dato-DXd will be prescribed for the labelled indication and has not received any dose of Dato-DXd prior to enrollment.

• Is willing to comply with use of prophylactic dexamethasone mouthwash at the start of first infusion and throughout Dato-DXd administration.

• ECOG performance status 0 or 1.

• Has adequate bone marrow function (hemoglobin ≥ 9 g/dL; red blood cell/plasma transfusion is not allowed within 1 week prior to screening assessment).

• All women of childbearing potential must have a negative serum pregnancy test result at screening.

• Informed Consent

• 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.

Locations
United States
Arkansas
Research Site
RECRUITING
Hot Springs
Research Site
RECRUITING
Little Rock
Arizona
Research Site
WITHDRAWN
Tucson
California
Research Site
NOT_YET_RECRUITING
Duarte
Research Site
RECRUITING
Glendale
Research Site
RECRUITING
Lakewood
Research Site
RECRUITING
Long Beach
Research Site
NOT_YET_RECRUITING
Torrance
Washington, D.c.
Research Site
WITHDRAWN
Washington D.c.
Florida
Research Site
NOT_YET_RECRUITING
Plantation
Georgia
Research Site
RECRUITING
Athens
Idaho
Research Site
WITHDRAWN
Boise
Illinois
Research Site
WITHDRAWN
Park Ridge
Indiana
Research Site
RECRUITING
Fort Wayne
Kentucky
Research Site
NOT_YET_RECRUITING
Elizabethtown
Research Site
NOT_YET_RECRUITING
Lexington
Research Site
NOT_YET_RECRUITING
Lexington
Research Site
NOT_YET_RECRUITING
Louisville
Louisiana
Research Site
NOT_YET_RECRUITING
New Orleans
Maryland
Research Site
WITHDRAWN
Frederick
Research Site
NOT_YET_RECRUITING
Glenn Dale
Michigan
Research Site
NOT_YET_RECRUITING
Detroit
Research Site
NOT_YET_RECRUITING
Grayling
Minnesota
Research Site
RECRUITING
Minneapolis
Missouri
Research Site
NOT_YET_RECRUITING
Kansas City
North Carolina
Research Site
NOT_YET_RECRUITING
Greensboro
Research Site
RECRUITING
Wilson
New Hampshire
Research Site
WITHDRAWN
Lebanon
Nevada
Research Site
WITHDRAWN
Reno
New York
Research Site
RECRUITING
East Syracuse
Research Site
NOT_YET_RECRUITING
Westbury
Research Site
WITHDRAWN
White Plains
Ohio
Research Site
NOT_YET_RECRUITING
Cleveland
Pennsylvania
Research Site
RECRUITING
Wynnewood
Tennessee
Research Site
NOT_YET_RECRUITING
Knoxville
Virginia
Research Site
NOT_YET_RECRUITING
Fairfax
Wisconsin
Research Site
NOT_YET_RECRUITING
Waukesha
West Virginia
Research Site
WITHDRAWN
Charleston
Research Site
NOT_YET_RECRUITING
Morgantown
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date: 2026-06-24
Estimated Completion Date: 2028-01-04
Participants
Target number of participants: 100
Treatments
Experimental: Dexamethasone 0.5 mg/5 mL Mouthwash
Participants will use dexamethasone 0.5 mg/5 mL alcohol-free mouthwash (10 mL, 4 times daily, swish for approximately 2 minutes, then spit out without swallowing).~Participants will remain without food or drink for at least 30 minutes after use of dexamethasone
Sponsors
Leads: AstraZeneca
Collaborators: Daiichi Sankyo

This content was sourced from clinicaltrials.gov

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