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

NCT06802757 | Recruiting Phase 2 DMC

• 1 other identifier: POS-PEM-Ⅱ-NEO-TNBC
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Triple-Negative Breast Cancer; Pathological Complete Response; Neoadjuvant Therapy; Posaconazole

Outcome Measures

Primary Outcomes (1)

• Pathological Complete Response

  Expected 25% increase in pCR rate

  24 weeks

Secondary Outcomes (5)

• Breast pathological complete response

  24 weeks

• Objective response rate

  24 weeks

• 3-year event-free survival rate

  After a median follow-up of 3 years

• Survival rate

  After a median follow-up of 3 years

• Security

  24 weeks

Study Arms (2)

Chemotherapy + PD-1 inhibitors

OTHER

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

Drug: Nab-paclitaxel; Drug: Carboplatin; Drug: Anthracycline; Drug: Cyclophosphamide; Drug: PD-1 inhibitors

Chemotherapy + PD-1 inhibitors+Posaconazole

EXPERIMENTAL

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

Drug: Posaconazole; Drug: Nab-paclitaxel; Drug: Carboplatin; Drug: Anthracycline; Drug: Cyclophosphamide; Drug: PD-1 inhibitors

Interventions

Nab-paclitaxel DRUG

Nab-paclitaxel 260mg/m2 d1 q21d

Chemotherapy + PD-1 inhibitors; Chemotherapy + PD-1 inhibitors+Posaconazole

Carboplatin DRUG

Carboplatin AUC=5-6 d1 q21d

Chemotherapy + PD-1 inhibitors; Chemotherapy + PD-1 inhibitors+Posaconazole

Anthracycline DRUG

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

Chemotherapy + PD-1 inhibitors; Chemotherapy + PD-1 inhibitors+Posaconazole

Cyclophosphamide DRUG

Cyclophosphamide 1000mg/m2 d1 q21d

Chemotherapy + PD-1 inhibitors; Chemotherapy + PD-1 inhibitors+Posaconazole

Posaconazole DRUG

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.

Chemotherapy + PD-1 inhibitors+Posaconazole

PD-1 inhibitors DRUG

Toripalimab, Pembrolizumab and Camrelizumab, etc.

Chemotherapy + PD-1 inhibitors; Chemotherapy + PD-1 inhibitors+Posaconazole

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female, aged ≥ 18 and ≤ 70 years old;
• first-confirmed TNBC;
• cT1cN1-3M0 or cT2-4N0-3M0;
• ECOG score 0-1 points.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shandong Cancer Hospital and Institute: lead

Study Sites (1)

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

Jinan, Shandong, 250117, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Triple Negative Breast Neoplasms

Interventions

posaconazole; 130-nm albumin-bound paclitaxel; Carboplatin; Anthracyclines; Cyclophosphamide; Immune Checkpoint Inhibitors

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Central Study Contacts

Pengfei Qiu, MD

CONTACT

+86053167626215; qiu.pf@outlook.com

Zhiqiang Shi, MD

CONTACT

+86053167626215; shizhiqiang1024@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 16, 2025
• First Posted: January 31, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): February 1, 2028
• Last Updated: February 25, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)