RecruitingEarly Phase 1NCT06637306

Neoadjuvant Dupilumab, Pembrolizumab, Paclitaxel, and Carboplatin in Locally Advanced Triple Negative Breast Cancer

Pilot Trial of the IL-4 Receptor Antagonist Dupilumab Plus Pembrolizumab, Paclitaxel, and Carboplatin in Locally Advanced Triple Negative Breast Cancer

Sponsor

Rima Patel

Enrollment

15 participants

Start Date

Mar 5, 2025

Study Type

INTERVENTIONAL

Conditions

TNBC - Triple-Negative Breast Cancer Locally Advanced Triple Negative Breast Cancer

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether adding dupilumab (an immune-modulating drug usually used for eczema) to the standard treatment for triple-negative breast cancer (TNBC) before surgery helps more tumors disappear completely. The full regimen includes pembrolizumab, paclitaxel, and carboplatin. **You may be eligible if...** - You are 18 or older with confirmed triple-negative breast cancer (no ER, PR, or HER2) - Your cancer is locally advanced: tumor 2 cm or larger, or has spread to nearby lymph nodes - You have not had any prior surgery, radiation, or chemotherapy for this breast cancer - You are in good overall health (ECOG score 0–1) - Your blood counts and organ function are within normal ranges **You may NOT be eligible if...** - You have already had surgery, radiation, or chemotherapy for this cancer - You are pregnant or breastfeeding - You have a serious autoimmune or immune-related condition - You are currently on immunosuppressive therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDupilumab

Dupilumab 600mg subcutaneous initial loading dose, 300mg for subsequent doses; administered every 3 weeks for 4 cycles. Immunotherapy drug FDA approved to treat patients with eczema, asthma, chronic rhinosinusitis with nasal polyps, and eosinophilic esophagitis. Investigational/not yet FDA approved to treat patients with breast cancer.

DRUGPembrolizumab

Pembrolizumab 200mg intravenous every 3 weeks for 4 cycles and one 400mg intravenous dose one week following completion of chemotherapy. Cancer immunotherapy drug FDA approved for the treatment of high-risk, early-stage, triple-negative breast cancer (TNBC).

DRUGPaclitaxel

Paclitaxel 80mg/m2 intravenous weekly for 12 weeks. Chemotherapy FDA-approved for the treatment of patients with breast cancer.

DRUGCarboplatin

Carboplatin AUC 1.5 intravenous weekly for 12 weeks. Chemotherapy FDA-approved for the treatment of patients with breast cancer.

Locations(1)

Mount Sinai Health System

New York, New York, United States

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NCT06637306

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