Combining Posaconazole with Pembrolizumab and Chemotherapy for Triple-Negative Breast Cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: qiu.pf@outlook.com
• Phone: +86053167626215

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.