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

Last updated: February 23, 2026
Sponsor: Shandong Cancer Hospital and Institute
Overall Status: Active - Recruiting

Phase

2

Condition

Breast Cancer

Cancer

Treatment

Pembrolizumab

Nab-paclitaxel

Posaconazole

Clinical Study ID

NCT06802757
POS-PEM-Ⅱ-NEO-TNBC
  • Ages 18-70
  • Female

Study 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.

Eligibility Criteria

Inclusion

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

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 localradiotherapy;

  4. No immune system disease or connective tissue disease;

  5. No history of hormone therapy;

  6. Pregnant/lactating.

Study Design

Total Participants: 72
Treatment Group(s): 7
Primary Treatment: Pembrolizumab
Phase: 2
Study Start date:
May 01, 2025
Estimated Completion Date:
February 01, 2028

Study Description

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.

Connect with a study center

  • Breast Cancer Center Shandong Cancer Hospital and Institute Shandong First Medical University and Shandong Academy of Medical Sciences

    Jinan, Shandong 250117
    China

    Site Not Available

  • Breast Cancer Center Shandong Cancer Hospital and Institute Shandong First Medical University and Shandong Academy of Medical Sciences

    Jinan 1805753, Shandong 1796328 250117
    China

    Active - Recruiting

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