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 @ 2:58 AM
Ignite Modification Date:
2025-12-25 @ 2:58 AM
NCT ID:
NCT05918133
Eligibility Criteria:
Inclusion Criteria:
1. Voluntarily participate in clinical research; fully understand the study and voluntarily sign the informed consent; willing to follow and have the ability to complete all trial procedures;
2. Male or female, aged 18 to 75 years (including boundary value);
3. Unresectable locally advanced or metastatic breast cancer confirmed by histology or cytology, ER, PR, HER-2 are all negative. Negative ER and PR were defined as: IHCER \< 1%, IHCPR \< 1%. HER-2 negative is defined as: IHCHER-2 (-) or (1+), HER-2 (2+) must be tested by FISH and the result is negative.
4. Patients who have not received systemic treatment for advanced TNBC in the past are allowed to use taxane anti-tumor therapy in the previous neoadjuvant and/or adjuvant treatment stage, but must meet the end time of taxane neoadjuvant and/or adjuvant treatment Recurrence/metastasis interval ≥ 12 months;
5. Sufficient organ function;
6. The Eastern Cooperative Oncology Group (ECOG) score of physical status is 0-1;
7. Expected survival period ≥ 12 weeks;
8. According to the RECIST1.1 standard, the subject has at least one measurable tumor lesion.
Exclusion Criteria:
1. History of severe allergic diseases, allergic history of serious drugs (including unlisted test drugs) or known allergic to any component of this test drug;
2. Previously received any antibody or inhibitor therapy targeting PD-1/PD-L1 or VEGF;
3. There is meningeal metastasis, uncontrollable or symptomatic central nervous system (CNS) metastasis;
4. Those who have active infection and currently need intravenous anti-infection treatment;
5. At present, there are uncontrollable pleural effusion, pericardium effusion and abdominal effusion;
6. Before the start of the study and treatment, fever of unknown cause \> 38.5°C (according to the researcher's judgment, fever caused by tumor can be included in the group);
7. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
8. Known history of alcohol abuse, psychotropic substance abuse or drug abuse;
9. Have a clear history of neurological or mental disorders, such as epilepsy, dementia and schizophrenia;
10. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS);
11. Syphilis nonspecific antibody test is positive (such as TRUST and PRP) or syphilis specific antibody test is positive (such as TPPA) \[it is acceptable that "Syphilis specific antibody test" is positive but "Syphilis nonspecific antibody test" is negative for more than one year\];
12. Active tuberculosis, or a history of tuberculosis infection in the past but failed to control after treatment;
13. Active hepatitis B (HBsAg positive and HBV-DNA ≥1 1000 IU/ml) can be controlled by antiviral drugs (HBV-DNA \< 1000 IU/ml). Active hepatitis C (HCV-RNA \> detection limit of research center);
14. According to the researcher's judgment, the subject's basic illness may increase the risk of receiving the study drug, or confuse the explanation of the toxic reaction and AE;
15. It is expected that any other form of anti-tumor drug treatment will be required during the study;
16. Women who are pregnant or breastfeeding.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05918133
Study Brief:
Protocol Section:
NCT05918133