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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

Study acronym: PRISM-TNBC
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated February 25, 2026 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Enrollment target: 20 to 72
    • Study description expanded, about 13 words
    v5
  2. Interventions: Anthracycline (Drug), Carboplatin (Drug), Cyclophosphamide (Drug), Nab-paclitaxel (Drug), Pembrolizumab (Drug), Posaconazole (Drug) to Anthracycline (Drug), Carboplatin (Drug), Cyclophosphamide (Drug), Nab-paclitaxel (Drug), PD-1 inhibitors (Drug), Posaconazole (Drug)
    • Study description revised
    • Study title expanded, about 2 words
    v4
  3. Start date changed from estimate of Feb 1, 2025 to May 1, 2025v3
  4. Study title expanded, about 10 wordsv2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06802757
Lead Sponsor Shandong Cancer Hospital and Institute
Conditions
(from sponsor)		 Breast Cancer
Related terms Breast Neoplasms, Triple Negative Breast Neoplasms
Enrollment 72 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov