Combining Posaconazole with Pembrolizumab and Chemotherapy 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

This study is testing whether adding a medication called posaconazole to standard chemotherapy and pembrolizumab can help women with high-risk triple-negative breast cancer respond better to treatment before surgery.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 72 (estimated)
• Ages: 18 Years to 70 Years
• Sex: Female
• Sponsor: Shandong Cancer Hospital and Institute (other)
• Drugs / interventions: pembrolizumab, chemotherapy, immunotherapy
• Locations: 1 site (Jinan, Shandong)
• Trial ID: NCT06802757 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of adding posaconazole to standard neoadjuvant chemotherapy and pembrolizumab in patients with high-risk triple-negative breast cancer (TNBC). The study aims to improve the pathological complete response (pCR) rate, which is crucial for patient outcomes. A total of 40 female patients aged 18 to 70 with early-stage TNBC will be recruited and randomly assigned to either the experimental group receiving posaconazole or a control group. Both groups will undergo standard treatment, followed by surgical evaluation of pCR rates after eight cycles of therapy.

Who should consider this trial

Good fit: Ideal candidates are females aged 18 to 70 with first-confirmed early-stage triple-negative breast cancer.

Not a fit: Patients with stage I or IV breast cancer or those with a history of other tumors may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly increase the rate of complete tumor response in patients with high-risk TNBC.

How similar studies have performed: While the combination of chemotherapy and immunotherapy has shown promise, the addition of posaconazole specifically in this context is a novel approach.

Eligibility criteria

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.

Where this trial is running

Jinan, Shandong

• Breast Cancer Center Shandong Cancer Hospital and Institute Shandong First Medical University and Shandong Academy of Medical Sciences — Jinan, Shandong, China (RECRUITING)

Study contacts

• Study coordinator: Pengfei Qiu, MD

Conditions: Breast Cancer, Triple-Negative Breast Cancer, Pathological Complete Response, Neoadjuvant Therapy, Posaconazole