Thymalfasin Combined With Chemotherapy and Immunotherapy in TNBC Neoadjuvant Treatment

- Patients must meet all of the following inclusion criteria to be enrolled in this study:

1. Female aged 18 to 70 years;
2. Histologically confirmed unilateral primary invasive breast cancer, planned to undergo neoadjuvant therapy (chemotherapy or at least 6 cycles of ADC therapy combined with immunotherapy);
3. Immunohistochemistry (IHC) confirmed triple-negative breast cancer (ER \<1%, PR \<1%, HER-2 0, or 1, or 2 with FISH negative);
4. At least one measurable lesion according to RECIST 1.1 criteria;

5. Major organ function essentially normal, meeting the following conditions:

   • Hematology criteria: HB ≥90 g/L (no transfusion within 14 days); ANC ≥1.5×10\^9/L; PLT ≥75×10\^9/L;
   • Biochemistry criteria: TBIL ≤1.5×ULN; ALT and AST ≤3×ULN; serum creatinine ≤1.5×ULN; estimated creatinine clearance >50 ml/min (Cockcroft-Gault formula);
6. ECOG performance status of 0-1;
7. LVEF ≥55%;
8. Female subjects of childbearing potential must use at least one medically recognized method of contraception during the study treatment and for at least 3 months after the last dose of the study drug;
9. Subjects voluntarily join this study, sign informed consent, demonstrate good compliance, and cooperate with follow-up.

Exclusion Criteria:

• Patients with any of the following conditions are not eligible to participate in this study:

  1. Patients who have previously received cytotoxic chemotherapy, endocrine therapy, biological therapy, or radiotherapy for any reason;
  2. Patients with heart disease classified as New York Heart Association (NYHA) class II or higher (including class II);
  3. Patients with severe systemic infections or other serious illnesses;
  4. Patients known to be allergic to or intolerant of the study drug or its excipients;
  5. Patients who have had other malignant tumors within the past 5 years, except for cured cervical carcinoma in situ or non-melanoma skin cancer;
  6. Pregnant or breastfeeding women, as well as women of childbearing potential who refuse to use appropriate contraceptive measures during the study;
  7. Patients who have previously undergone organ transplantation;
  8. Patients deemed by the investigator to be unsuitable for participation in the study.