Status:
NOT_YET_RECRUITING
The Efficacy of Oral Cryotherapy in Preventing TROP2-ADC-Induced Oral Mucositis in Patients With Advanced Breast Cancer
Lead Sponsor:
Henan Cancer Hospital
Conditions:
Advanced or Metastatic Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The incidence of oral mucositis associated with TROP2-ADC therapy in patients with advanced breast cancer is notably high. Identifying effective preventive and therapeutic strategies is essential for ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2027
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT06934733
Start Date
May 1 2025
End Date
May 1 2027
Last Update
April 18 2025
Active Locations (1)
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1
Henan Cancer Hospital
Zhengzhou, Henan, China