RecruitingPhase 2NCT06802757

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

A Phase II, Randomised, Open-label, Multicentre Study of Posaconazole Plus PD-1 Inhibitors and Chemotherapy Versus PD-1 Inhibitors and Chemotherapy as Neoadjuvant Therapy for Triple Negative Breast Cancer


Sponsor

Shandong Cancer Hospital and Institute

Enrollment

72 participants

Start Date

May 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding an antifungal medication called posaconazole to standard immunotherapy and chemotherapy improves treatment response in women with triple-negative breast cancer (TNBC) — an aggressive type of breast cancer that lacks hormone receptors. **You may be eligible if...** - You are a woman between 18 and 70 years old - You have been newly diagnosed with triple-negative breast cancer - Your cancer is stage II or III (locally advanced but not yet spread to distant organs) - Your performance status is good (ECOG 0–1) **You may NOT be eligible if...** - Your cancer is stage I or stage IV - You have a history of previous breast cancer - You have an immune system disease or connective tissue disorder - You have received previous hormone therapy - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPosaconazole

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.

DRUGNab-paclitaxel

Nab-paclitaxel 260mg/m2 d1 q21d

DRUGCarboplatin

Carboplatin AUC=5-6 d1 q21d

DRUGAnthracycline

Epirubicin 90-100mg/m2 d1 q21d or Doxorubicin 50-60mg/m2 d1 q21d

DRUGCyclophosphamide

Cyclophosphamide 1000mg/m2 d1 q21d

DRUGPD-1 inhibitors

Toripalimab, Pembrolizumab and Camrelizumab, etc.


Locations(1)

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

Jinan, Shandong, China

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NCT06802757


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