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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Female, aged ≥ 18 and ≤ 70 years old;

• first-confirmed TNBC;

• cT1cN1-3M0 or cT2-4N0-3M0;

• ECOG score 0-1 points.

Locations
Other Locations
China
Breast Cancer Center Shandong Cancer Hospital and Institute Shandong First Medical University and Shandong Academy of Medical Sciences
RECRUITING
Jinan
Contact Information
Primary
Pengfei Qiu, MD
qiu.pf@outlook.com
+86053167626215
Backup
Zhiqiang Shi, MD
shizhiqiang1024@163.com
+86053167626215
Time Frame
Start Date: 2025-05-01
Estimated Completion Date: 2028-02-01
Participants
Target number of participants: 20
Treatments
Other: Chemotherapy + PD-1 inhibitor
Nab-paclitaxel + carboplatin 4 cycles, sequential anthracycline + cyclophosphamide 4 cycles in combination with pembrolizumab
Experimental: Chemotherapy + PD-1 inhibitor+Posaconazole
Nab-paclitaxel + carboplatin 4 cycles, sequential anthracycline + cyclophosphamide 4 cycles in combination with pembrolizumab and posaconazole
Sponsors
Leads: Shandong Cancer Hospital and Institute

This content was sourced from clinicaltrials.gov