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 @ 11:04 PM
Ignite Modification Date:
2025-12-24 @ 11:04 PM
NCT ID:
NCT06448169
Eligibility Criteria:
Inclusion Criteria:
1. Age: 18-60 years old;
2. Histologically confirmed triple-negative breast cancer, with immunohistochemistry showing ER \<1%, PR \<1%, HER2-negative (IHC 0 or 1+; or IHC 2+ ISH-negative);
3. Imaging-confirmed non-metastatic disease;
4. Clinical efficacy can be evaluated according to RECIST criteria;
5. European Functional Handicap Scale (MRC) of 0-2;
6. The investigator determines that the treatment is tolerable based on the patient's organ function level;
7. Volunteers willing to participate in this study, sign the informed consent, have good compliance, and are willing to cooperate with follow-up.
Exclusion Criteria:
1. Immunohistochemistry showing HER2-positive (IHC 3 or IHC 2 ISH-amplified);
2. Previously treated;
3. Severe dysfunction of important organs such as heart, liver, and kidneys;
4. Patients with diseases unsuitable for immunotherapy;
5. Known allergy history to any component of the drugs in this regimen;
6. History of immune deficiency, including HIV-positive, HCV, active hepatitis B, or other acquired or congenital immune deficiency diseases, or a history of organ transplantation;
7. Any cardiac disease, including: ① Medically treated or clinically significant arrhythmias; ② Myocardial infarction; ③ Heart failure; ④ Any other cardiac disease judged by the investigator as unsuitable for participation in this trial;
8. Pregnant or lactating women, fertile women with positive baseline pregnancy test or those unwilling to take effective contraceptive measures during the entire trial;
9. According to the investigator's judgment, there are accompanying diseases that seriously endanger the safety of the patient or affect the completion of the study (including but not limited to severe hypertension uncontrollable by drugs, severe diabetes, active infections, etc.);
10. Long-term use of drugs that affect the components of peripheral blood immune cells, such as recombinant human erythropoietin, recombinant human granulocyte colony-stimulating factor, recombinant human interleukin, or Likejun tablets;
11. Received immunosuppressive therapy within 2 weeks;
12. Hematological precancerous diseases, such as myelodysplastic syndrome, and coagulation disorders.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT06448169
Study Brief:
Protocol Section:
NCT06448169