Study on Preventing Mouth Sores in Patients Taking Datopotamab Deruxtecan for Advanced Breast or Lung Cancer

Sponsor: AstraZeneca

Sponsor score: 40

ClinicalTrials ID:NCT07357597

Provider View

This clinical trial is testing a mouthwash to prevent mouth sores in patients receiving Datopotamab Deruxtecan (Dato-DXd) for advanced breast or lung cancer. The study aims to see if the mouthwash can reduce the severity of mouth sores during treatment.

Patient Parameters

Program Overview

This study is exploring whether using a dexamethasone mouthwash can help prevent or reduce mouth sores in patients being treated with Datopotamab Deruxtecan (Dato-DXd) for advanced breast cancer or lung cancer with a specific mutation. The trial will involve about 100 participants across the U.S., who will use the mouthwash during their cancer treatment.

Description

The purpose of this study is to see if a special mouthwash can help prevent or lessen mouth sores in patients taking Datopotamab Deruxtecan (Dato-DXd) for advanced breast or lung cancer. The study will include about 100 participants at 35 locations in the U.S. Participants will be divided into two groups: one for breast cancer and one for lung cancer. Each group will have about 50 participants.

Participants will use a dexamethasone mouthwash while receiving their regular cancer treatment with Dato-DXd. The study will last for about 18 months, with each participant being followed for at least 12 weeks after starting the treatment. The goal is to understand how often and how severe the mouth sores are when using the mouthwash.

Eligibility Criteria

Inclusion Criteria

  • Have advanced breast cancer that cannot be removed by surgery or has spread, and have received previous hormone and chemotherapy treatments.
  • Have advanced triple-negative breast cancer (TNBC) that cannot be treated with certain immunotherapies.
  • Have advanced lung cancer with a specific mutation (EGFRm) and have received previous targeted and chemotherapy treatments.
  • Be 18 years or older.
  • Have not received Datopotamab Deruxtecan (Dato-DXd) before joining the study.
  • Be willing to use the dexamethasone mouthwash during treatment.
  • Have a performance status score of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have adequate bone marrow function, with specific blood counts.
  • Women of childbearing potential must have a negative pregnancy test before starting the study.
  • Be able to understand and sign an informed consent form.

Exclusion Criteria

  • Have already received Datopotamab Deruxtecan (Dato-DXd) before joining the study.
  • Have certain heart, lung, or kidney conditions that make participation unsafe.
  • Have active and uncontrolled mouth sores or ulcers at the start of the study.
  • Cannot use steroid mouthwash due to active oral infections or allergies to its ingredients.
  • Have uncontrolled infections requiring IV treatment.
  • Have significant eye disease affecting the cornea.
  • Have severe allergies to the study drug or its ingredients.
  • Have severe allergies to other similar medications.
  • Are pregnant, breastfeeding, or planning to become pregnant.
  • Are involved in planning or conducting the study.
  • Are unlikely to follow study procedures and requirements.
  • Have previously participated in this study.

Locations

FACILITYZIPCITYSTATE
Research Site85719TucsonArizona
Research Site71913Hot SpringsArkansas
Research Site72205Little RockArkansas
Research Site91010DuarteCalifornia
Research Site91204GlendaleCalifornia
Research Site90805LakewoodCalifornia
Research Site90806Long BeachCalifornia
Research Site90505TorranceCalifornia
Research Site20037Washington D.C.District of Columbia
Research Site33322PlantationFlorida

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