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

ConditionBreast Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorShandong Cancer Hospital and Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female, aged ≥ 18 and ≤ 70 years old;

first-confirmed TNBC;

cT1cN1-3M0 or cT2-4N0-3M0;

ECOG score 0-1 points.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • Nab-paclitaxel

    Drug

    Nab-paclitaxel 260mg/m2 d1 q21d

  • Carboplatin

    Drug

    Carboplatin AUC=5-6 d1 q21d

  • Anthracycline

    Drug

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

  • Cyclophosphamide

    Drug

    Cyclophosphamide 1000mg/m2 d1 q21d

  • PD-1 inhibitors

    Drug

    Toripalimab, Pembrolizumab and Camrelizumab, etc.

Treatment groups

72 Participants
are divided into 2 treatment groups
Group A: Chemotherapy + PD-1 inhibitorsOther 5 interventions
Group B: Chemotherapy + PD-1 inhibitors+PosaconazoleExperimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

Pathological Complete Response

Expected 25% increase in pCR rate

Time frame
24 weeks

Secondary outcomes

1

Breast pathological complete response

Time frame
24 weeks
2

Objective response rate

Time frame
24 weeks
3

3-year event-free survival rate

Time frame
After a median follow-up of 3 years
4

Survival rate

Time frame
After a median follow-up of 3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shandong Cancer Hospital and Institute

Lead sponsor

Source ClinicalTrials.gov
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