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:
2025-12-24 @ 1:05 PM
Ignite Modification Date:
2025-12-24 @ 1:05 PM
NCT ID:
NCT05353361
Eligibility Criteria:
Inclusion Criteria:
1. Women aged 18 to 75 (inclusive)
2. Breast cancer confirmed by histology or cytology.
3. ECOG score is 0 or 1
4. An expected survival of ≥ 12 weeks
5. At least one measurable lesion according to RECIST v1.1 criteria
6. Have adequate renal and hepatic function
7. Patients voluntarily joined the study and signed informed consent
Exclusion Criteria:
1. Have other malignancies within the past 5 years
2. Active central nervous system metastasis without surgery or radiotherapy
3. Presence with uncontrollable third space effusion
4. Have undergone other anti-tumor treatment within 4 weeks before the first dose
5. Immunosuppressant or systemic hormone therapy was used within 2 weeks prior to the first dose
6. Any active autoimmune disease or a history of autoimmune disease
7. A history of immune deficiency
8. Clinically significant cardiovascular disorders
9. Clinically significant history of lung disease
10. The toxicity from previous anti-tumor treatment has not recovered to ≤ grade I
11. Known hereditary or acquired bleeding tendency
12. Active hepatitis and liver cirrhosis
13. Presence of other serious physical or mental diseases or laboratory abnormalities
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05353361
Study Brief:
Protocol Section:
NCT05353361