RecruitingStomatitis

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.

Eligible age

18+ yrs

Accepts

All genders

Locations

25 states

Healthy volunteers

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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

Sponsor: AstraZeneca

You may qualify if…

✓ 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.

You may not qualify if…

✕ 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