drugset / Trial / NCT06802757

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

NCT06802757

Phase 2 Recruiting 72 enrolled Shandong Cancer Hospital and Institute
RandomizedParallel-groupOpen-labelTreatment

Summary

Triple-negative breast cancer (TNBC) is as sociated with shorter overall survival than other breast cancer subtypes, despite the use of curative-intent anthracycline- and taxane-based systemic chemotherapy. Neoadjuvant therapy is now also recognized as the standard treatment for patients with high-risk TNBC. The Keynote-522 study demonstrated that the application of pembrolizumab has raised the pathological Complete Response (pCR) rate in TNBC to over 60%, but nearly 40% of patients still do not achieve pCR. How to further improve the pCR rate in TNBC patients has become a hot topic of current research. Posaconazole is an antibiotic used to prevent invasive Aspergillus and Candida infections and to treat oropharyngeal candidiasis. Our preclinical studies have found that posaconazole can inhibit immune cell-mediated steroidogenesis to restrict TNBC tumor progression. The investigators design and begin a a prospective randomized controlled clinical study to explore the effectiveness of posaconazole in the neoadjuvant treatment of TNBC.

Timeline

Start
2025-05-01
Primary completion
2026-06-30
Completion
2028-02-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Posaconazole Small molecule 300 mg Oral
Background Camrelizumab Monoclonal antibody
Background Carboplatin Small molecule
Background Cyclophosphamide Other / unclassified 1000 mg/m2
Background Doxorubicin Other / unclassified 50 mg/m2
Background Doxorubicin Other / unclassified 60 mg/m2
Background Epirubicin Small molecule 90 mg/m2
Background Epirubicin Small molecule 100 mg/m2
Background Paclitaxel Small molecule 260 mg/m2
Background Pembrolizumab Monoclonal antibody
Background Toripalimab Monoclonal antibody

Indications