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

NCT ID: NCT06802757

Last Updated: 2026-02-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2028-02-01

Brief 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.

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: 300 mg po bid, from Day 2, start maintenance dose at 300 mg po qd, q21d). 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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Chemotherapy + PD-1 inhibitors

Nab-paclitaxel + carboplatin 4 cycles, sequential anthracycline + cyclophosphamide 4 cycles in combination with PD-1 inhibitors

Group Type: OTHER

Nab-paclitaxel

Intervention Type: DRUG

Nab-paclitaxel 260mg/m2 d1 q21d

Carboplatin

Intervention Type: DRUG

Carboplatin AUC=5-6 d1 q21d

Anthracycline

Intervention Type: DRUG

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

Cyclophosphamide

Intervention Type: DRUG

Cyclophosphamide 1000mg/m2 d1 q21d

PD-1 inhibitors

Intervention Type: DRUG

Pembrolizumab, etc.

Chemotherapy + PD-1 inhibitors+Posaconazole

Nab-paclitaxel + carboplatin 4 cycles, sequential anthracycline + cyclophosphamide 4 cycles in combination with PD-1 inhibitors and posaconazole

Group Type: EXPERIMENTAL

Posaconazole

Intervention Type: DRUG

Day 1: 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.

Nab-paclitaxel

Intervention Type: DRUG

Nab-paclitaxel 260mg/m2 d1 q21d

Carboplatin

Intervention Type: DRUG

Carboplatin AUC=5-6 d1 q21d

Anthracycline

Intervention Type: DRUG

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

Cyclophosphamide

Intervention Type: DRUG

Cyclophosphamide 1000mg/m2 d1 q21d

PD-1 inhibitors

Intervention Type: DRUG

Pembrolizumab, etc.

Interventions

Posaconazole

Day 1: 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.

Intervention Type: DRUG

Nab-paclitaxel

Nab-paclitaxel 260mg/m2 d1 q21d

Intervention Type: DRUG

Carboplatin

Carboplatin AUC=5-6 d1 q21d

Intervention Type: DRUG

Anthracycline

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

Intervention Type: DRUG

Cyclophosphamide

Cyclophosphamide 1000mg/m2 d1 q21d

Intervention Type: DRUG

PD-1 inhibitors

Pembrolizumab, etc.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Shandong Cancer Hospital and Institute

OTHER

Sponsor Role: lead

Responsible Party

Yongsheng Wang

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Jinan, Shandong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Pengfei Qiu, MD

Role: CONTACT

qiu.pf@outlook.com

+86053167626215

Zhiqiang Shi, MD

Role: CONTACT

shizhiqiang1024@163.com

+86053167626215

Facility Contacts

Pengfei Qiu

Role: primary

qiu.pf@outlook.com

+86053167626215

Other Identifiers

POS-PEM-Ⅱ-NEO-TNBC

Identifier Type: -

Identifier Source: org_study_id