OncoMatch/Clinical Trials/NCT06637306
Neoadjuvant Dupilumab, Pembrolizumab, Paclitaxel, and Carboplatin in Locally Advanced Triple Negative Breast Cancer
Is NCT06637306 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies multiple treatments including Dupilumab and Pembrolizumab for locally advanced triple negative breast cancer.
Treatment: Dupilumab · Pembrolizumab · Paclitaxel · Carboplatin — Pilot trial of the IL-4 receptor antagonist dupilumab plus pembrolizumab, paclitaxel, and carboplatin in locally advanced triple negative breast cancer (TNBC). Primary Objective: To assess the safety of neoadjuvant dupilumab and pembrolizumab plus weekly paclitaxel and carboplatin as measured by the proportion of severe immune-related adverse events (irAEs) in patients with locally advanced TNBC. Secondary Objectives: To determine the rates of pathologic complete response with the addition of dupilumab to NAC and pembrolizumab; to determine the rate of residual cancer burden 0-1; to estimate the recurrence-free survival and overall survival; to assess the toxicity of the combination of dupilumab, pembrolizumab, and paclitaxel-carboplatin.
Check if I qualifyExtracted eligibility criteria
Cancer type
Triple-Negative Breast Cancer
Breast Carcinoma
Disease stage
Required: Stage T2-4N0, T1C-T4N1-3
Excluded: Stage IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: chemotherapy
no prior definitive breast surgery, radiation therapy, or systemic chemotherapy with therapeutic intent for this breast cancer
Cannot have received: radiation therapy
no prior definitive breast surgery, radiation therapy, or systemic chemotherapy with therapeutic intent for this breast cancer
Cannot have received: surgery
no prior definitive breast surgery, radiation therapy, or systemic chemotherapy with therapeutic intent for this breast cancer
Cannot have received: investigational agent
Patients may not be receiving any other investigational agents
Lab requirements
Blood counts
absolute neutrophil count ≥ 1,500/mcL; platelets ≥ 100,000/mcl
Kidney function
creatinine within normal institutional limits
Liver function
total bilirubin within normal institutional limits; AST(SGOT)/ALT(SPGT) ≤ 2.5 X institutional upper limit of normal
Adequate organ and marrow function as defined below: * absolute neutrophil count ≥ 1,500/mcL * platelets ≥ 100,000/mcl * total bilirubin within normal institutional limits * AST(SGOT)/ALT(SPGT) ≤ 2.5 X institutional upper limit of normal * creatinine within normal institutional limits
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Mount Sinai Health System · New York, New York
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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