Non-Inferiority Study on MRNA-lncRNA Model in Low-Risk Triple-Negative Breast Cancer Patients

Prior treatment

• Patients who have received neoadjuvant treatment, including chemotherapy, targeted therapy, radiotherapy, or endocrine therapy.

Other illness

• Bilateral breast cancer.
• Any \>T4 lesions (UICC1987) (involving skin invasion, tumor fixation, or inflammatory breast cancer).
• History of clinically significant or uncontrolled heart disease, including congestive heart failure, angina, myocardial infarction within the past 6 months, or ventricular arrhythmias.
• 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.
• Severe or uncontrolled infections.
• Known active HBV or HCV infection, or HBV DNA ≥ 500, or chronic infection with abnormal liver function.
• History of substance abuse that cannot be quit or any psychiatric disorders.

Other

• Metastasis at any site.
• Pregnant or breastfeeding women, or women of childbearing potential who are unable to use effective contraception.
• Patients concurrently participating in other clinical trials.
• Patients deemed unsuitable for the study by the investigator.

• Female participants aged ≥18 and ≤70 years.
• ECOG performance status of 0 to 1.
• 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.
• Postoperative early-stage breast cancer patients who have undergone radical surgery, with pathological TNM staging of pT1c-3N0-3M0.
• 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).
• 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.
• Participants must voluntarily join the study, sign the informed consent form, demonstrate good compliance, and cooperate with follow-up procedures.