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

RecruitingPhase 2Ages 18 Years - 70 YearsFemaleShandong Cancer Hospital and Institute
NCT06802757 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 de

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📋 Eligibility rules (as published)
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.
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What it tests

  • Posaconazole
  • Nab-paclitaxel
  • Carboplatin
  • Anthracycline
  • Cyclophosphamide
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Where

1 site
Breast Cancer Center Shandong Cancer Hospital and Institute Shandong First Medical University and Shandong Academy of Medical Sciences
Jinan, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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