Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-25 @ 2:46 AM
NCT ID:
NCT06934733
Eligibility Criteria:
Inclusion Criteria:
1. Participants voluntarily enrolled in the study, signed the informed consent form, and demonstrated good compliance.
2. Age ≥ 18 years at the time of informed consent signing.
3. Patients with locally advanced or recurrent/metastatic breast cancer receiving TROP2-ADC treatment for the first time.
4. ECOG PS: 0-2 points;
5. The expected survival time was more than 3 months;
6. 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:
1. Blood routine: Neutrophil count (NEUT#) ≥ 1.5×109/L; Platelet (PLT) ≥ 75×109/L; Hemoglobin ≥ 90g/L
2. Liver function: AST and ALT ≤ 3 × ULN; for patients with liver metastasis, AST and ALT ≤ 5 × ULN.
3. Renal function: Creatinine ≤ 1.5 × ULN or Ccr ≥ 60 ml/min (Cockcroft-Gault formula provided).
4. Cardiac function: LVEF ≥ 50% by ECHO or MUGA scan.
7. 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.
8. Voluntary participants who sign informed consent, demonstrate good compliance, and agree to follow-up.
Exclusion Criteria:
1. Prior TROP2-targeted treatment was administered.
2. Patients with active oral mucositis or oral ulcers were excluded.
3. 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.
4. Other conditions where the investigator determines the patient is unsuitable for study participation.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT06934733
Study Brief:
Protocol Section:
NCT06934733