The Efficacy of Oral Cryotherapy in Preventing TROP2-ADC-Induced Oral Mucositis in Patients With Advanced Breast Cancer

Inclusion criteria

• Participants voluntarily enrolled in the study, signed the informed consent form, and demonstrated good compliance.
• Age ≥ 18 years at the time of informed consent signing.
• Patients with locally advanced or recurrent/metastatic breast cancer receiving TROP2-ADC treatment for the first time.
• ECOG PS: 0-2 points;
• The expected survival time was more than 3 months;
• Adequate organ and bone marrow function, with no transfusions or treatments with recombinant human thrombopoietin or colony-stimulating factors within 1 week before the first dose, is defined as follows:

• Blood routine: Neutrophil count (NEUT#) ≥ 1.5×109/L; Platelet (PLT) ≥ 75×109/L; Hemoglobin ≥ 90g/L
• Liver function: AST and ALT ≤ 3 × ULN; for patients with liver metastasis, AST and ALT ≤ 5 × ULN.
• Renal function: Creatinine ≤ 1.5 × ULN or Ccr ≥ 60 ml/min (Cockcroft-Gault formula provided).
• Cardiac function: LVEF ≥ 50% by ECHO or MUGA scan.
• Patients with a negative pregnancy test and reproductive potential must agree to use effective non-hormonal contraception during treatment and for at least 3 months after the last dose of the investigational drug.
• Voluntary participants who sign informed consent, demonstrate good compliance, and agree to follow-up.

Exclusion criteria

• Prior TROP2-targeted treatment was administered.
• Patients with active oral mucositis or oral ulcers were excluded.
• Patients with serious concomitant diseases, as judged by researchers, that threaten safety or impede study completion, including uncontrolled hypertension, severe diabetes, and active infections, were excluded.
• Other conditions where the investigator determines the patient is unsuitable for study participation.