Posaconazole Plus PD-1 Inhibitors and Chemotherapy vs PD-1 Inhibitors and Chemotherapy in Neoadjuvant Therapy for Triple Negative Breast Cancer

OBJECTIVES: On the basis of chemotherapy combined with immunotherapy, posaconazole was used to further improve the pathological complete response (pCR) rate of high-risk triple-negative breast cancer (TNBC), and to explore biomarkers.

OUTLINE: From february 1st, 2025 to june 30th, 2026 the investigators will recruit 72 patients with first-time diagnosed early-stage TNBC. Enrolled patients were randomly divided into experimental group and control group on a 1:1 basis. Both groups received standard neoadjuvant chemotherapy combined with immunotherapy. The experimental group was treated with posaconazole (Day 1 of Cycle 1 only: 300 mg bid; from Day 2, maintenance dose of 300 mg qd, oral administration. 21 days per treatment cycle, for a total of 8 cycles.). Standard surgical treatment was performed after 8 cycles and the surgical specimens were pathologically tested to compare the differences in pCR rates between the two groups.

Inclusion criteria

• Female, aged ≥ 18 and ≤ 70 years old;
• first-confirmed TNBC;
• cT1cN1-3M0 or cT2-4N0-3M0;
• ECOG score 0-1 points.

Exclusion criteria

• Stage I or IV;
• History of previous breast cancer;
• Patients with a history of other tumors who have received systemic therapy or local radiotherapy;
• No immune system disease or connective tissue disease;
• No history of hormone therapy;
• Pregnant/lactating.