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 @ 7:44 PM
Ignite Modification Date:
2025-12-24 @ 7:44 PM
NCT ID:
NCT06795503
Eligibility Criteria:
Inclusion Criteria:
1. Female participants aged ≥18 and ≤70 years.
2. ECOG performance status of 0 to 1.
3. Histologically confirmed invasive triple-negative breast cancer (TNBC), defined as breast cancer with estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER2) all determined to be negative by pathological testing. Specifically, ER-negative: IHC \<1%, PR-negative: IHC \<1%, HER2-negative: IHC -/+ or IHC++ but FISH/CISH negative. Tissue samples must be verified by the central lead institution as low-risk according to the mRNA-lncRNA model.
4. Postoperative early-stage breast cancer patients who have undergone radical surgery, with pathological TNM staging of pT1c-3N0-3M0.
5. Normal major organ function, meeting the following criteria: ① Hematological examination standards: HB ≥ 90g/L (no blood transfusion within the last 14 days); ANC ≥ 1.5×10⁹/L; PLT ≥ 75×10⁹/L; ② Biochemical examination standards: TBIL ≤ 1.5×ULN (upper limit of normal); ALT and AST ≤ 3×ULN; Serum Cr ≤ 1×ULN, and creatinine clearance rate \> 50ml/min (Cockcroft-Gault formula).
6. Women of childbearing potential must use medically approved contraception during the study treatment period and for at least 3 months after the last dose of the study drug.
7. Participants must voluntarily join the study, sign the informed consent form, demonstrate good compliance, and cooperate with follow-up procedures.
Exclusion Criteria:
1. Patients who have received neoadjuvant treatment, including chemotherapy, targeted therapy, radiotherapy, or endocrine therapy.
2. Bilateral breast cancer.
3. Metastasis at any site.
4. Any \>T4 lesions (UICC1987) (involving skin invasion, tumor fixation, or inflammatory breast cancer).
5. History of clinically significant or uncontrolled heart disease, including congestive heart failure, angina, myocardial infarction within the past 6 months, or ventricular arrhythmias.
6. History of other malignancies within the past 5 years, except for cured in situ cervical cancer, basal cell carcinoma, or squamous cell carcinoma of the skin.
7. Pregnant or breastfeeding women, or women of childbearing potential who are unable to use effective contraception.
8. Patients concurrently participating in other clinical trials.
9. Severe or uncontrolled infections.
10. Known active HBV or HCV infection, or HBV DNA ≥ 500, or chronic infection with abnormal liver function.
11. History of substance abuse that cannot be quit or any psychiatric disorders.
12. Patients deemed unsuitable for the study by the investigator.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT06795503
Study Brief:
Protocol Section:
NCT06795503