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 @ 9:58 PM
Ignite Modification Date:
2025-12-24 @ 9:58 PM
NCT ID:
NCT07111832
Eligibility Criteria:
Inclusion Criteria:
1. Age 18-75 years old (including both ends), female.
2. Pathologically confirmed locally recurrent unresectable or metastatic triple-negative breast cancer.
3. Expected survival ≥ 12 weeks.
4. Have adequate renal and hepatic function.
5. Patients voluntarily joined the study and signed the informed consent.
Exclusion Criteria:
1. Patients with active central nervous system (CNS) metastases who have not undergone surgery or radiotherapy.
2. Have other malignancies within the past 5 years.
3. Presence with uncontrollable third space effusion.
4. Have undergone other anti-tumor treatment within 4 weeks before the first dose.
5. A history of immunodeficiency.
6. Clinically significant cardiovascular diseases.
7. Known or suspected interstitial lung disease.
8. Known hereditary or acquired bleeding tendency.
9. Toxicities from prior anti-tumor therapy that have not recovered to ≤ Grade 1.
10. Known hypersensitivity to any of the study drugs or their excipients, or a history of allergy to humanized monoclonal antibody products.
11. Presence of other severe physical or mental disorders or clinically significant laboratory abnormalities.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07111832
Study Brief:
Protocol Section:
NCT07111832