Thymalfasin Combined With Chemotherapy and Immunotherapy for Neoadjuvant Treatment of Triple-Negative Breast Cancer：A Prospective, Open-Label, Single-Center, Phase II, Randomized Controlled Clinical Study
| Registry | NCT07884201 |
|---|---|
| Status | Not yet recruiting |
| Phase | Phase 2 |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 572 (Estimated) |
| Sponsor | Fudan University (Other) |
| Conditions | Breast Cancer, TNBC - Triple-Negative Breast Cancer, Immunotherapy |
| Interventions | Thymalfasin (Drug) |
| Dates | start 2026-11-08 (estimated), primary completion 2029-11-07 (estimated), completion 2031-10-08 (estimated), first posted 2026-10-20, last updated 2026-10-20 |
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This is a prospective, open-label, single-center, phase II, randomized controlled clinical trial involving patients with triple-negative breast cancer who meet the criteria for neoadjuvant chemotherapy (T > 2 cm, N+). The study aims to further validate the sensitizing effect and safety of Thymalfasin in combination with neoadjuvant chemotherapy and immunotherapy by comparing the 3-year event-free survival (EFS) and IFNγ elevation rates between the group receiving Thymalfasin in combinatione with standard neoadjuvant chemotherapy and immunotherapy and the control group receiving standard neoadjuvant chemotherapy and immunotherapy alone.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Thymalfasin Arm | Experimental | Drug: Thymalfasin | |
| Control Arm | No intervention |
Sex: Female, ages: 18 Years to 70 Years
Inclusion Criteria: \- 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.