Recruiting

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

ClinicalTrials.gov IDNCT06802757

PhasePHASE2

Enrollment72

SponsorShandong Cancer Hospital and Institute

Age18 Years – 70 Years

SexFEMALE

I'm interested View official listing

Conditions studied

Breast Cancer

About this study

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.

Interventions

Drug: 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.
Drug: Nab-paclitaxel — Nab-paclitaxel 260mg/m2 d1 q21d
Drug: Carboplatin — Carboplatin AUC=5-6 d1 q21d
Drug: Anthracycline — Epirubicin 90-100mg/m2 d1 q21d or Doxorubicin 50-60mg/m2 d1 q21d
Drug: Cyclophosphamide — Cyclophosphamide 1000mg/m2 d1 q21d
Drug: PD-1 inhibitors — Toripalimab, Pembrolizumab and Camrelizumab, etc.

Primary outcomes

Pathological Complete Response (24 weeks)

Eligibility information

Inclusion Criteria: 1. Female, aged ≥ 18 and ≤ 70 years old; 2. first-confirmed TNBC; 3. cT1cN1-3M0 or cT2-4N0-3M0; 4. ECOG score 0-1 points. Exclusion Criteria: 1. Stage I or IV; 2. History of previous breast cancer; 3. Patients with a history of other tumors who have received systemic therapy or local radiotherapy; 4. No immune system disease or connective tissue disease; 5. No history of hormone therapy; 6. Pregnant/lactating.

Study locations

Breast Cancer Center Shandong Cancer Hospital and Institute Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, Shandong 250117 China

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-05.