Posaconazole Plus PD-1 Inhibitors and Chemotherapy vs PD-1 Inhibitors and Chemotherapy in Neoadjuvant Therapy for Triple Negative Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Posaconazole, Nab-paclitaxel, Carboplatin, Anthracycline.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: 18 years — 70 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Detailed 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.
Interventions
- Drug 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. - Drug Nab-paclitaxel
Nab-paclitaxel 260mg/m2 d1 q21d - Drug Carboplatin
Carboplatin AUC=5-6 d1 q21d - Drug Anthracycline
Epirubicin 90-100mg/m2 d1 q21d or Doxorubicin 50-60mg/m2 d1 q21d - Drug Cyclophosphamide
Cyclophosphamide 1000mg/m2 d1 q21d - Drug PD-1 inhibitors
Toripalimab, Pembrolizumab and Camrelizumab, etc.
Primary outcome measures
- Pathological Complete Response [Time frame: 24 weeks]
Secondary outcome measures (5)
- Breast pathological complete response [Time frame: 24 weeks]
- Objective response rate [Time frame: 24 weeks]
- 3-year event-free survival rate [Time frame: After a median follow-up of 3 years]
- Survival rate [Time frame: After a median follow-up of 3 years]
- Security [Time frame: 24 weeks]
Eligibility criteria
Inclusion criteria
- Female, aged ≥ 18 and ≤ 70 years old;
- first-confirmed TNBC;
- cT1cN1-3M0 or cT2-4N0-3M0;
- ECOG score 0-1 points.
Exclusion criteria
- Stage I or IV;
- History of previous breast cancer;
- Patients with a history of other tumors who have received systemic therapy or local radiotherapy;
- No immune system disease or connective tissue disease;
- No history of hormone therapy;
- Pregnant/lactating.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Breast Cancer Center Shandong Cancer Hospital and Institute Shandong First Medical Univers — Jinan
Identifiers
NCT: NCT06802757 · POS-PEM-Ⅱ-NEO-TNBC