Breast cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. The patient has been histologically diagnosed with invasive breast cancer. 2. The patient has been diagnosed with metastatic or recurrent breast cancer. 3. The patient is 18 years of age or older at the time of consent. 4. The patient has a performance status (PS) of 0 or 1. 5. The patient is scheduled to receive Dato-DXd treatment. 6. Written informed consent for participation in the study has been obtained.
Exclusion criteria
Exclusion criteria: 1. The patient has oral mucositis prior to study enrollment. 2. The patient is pregnant or breastfeeding. 3. The patient has an active infection requiring treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of oral mucositis by Day 56 from treatment initiation. | — |
Countries
Japan
Contacts
Toranomon hospital Department of medical oncology