Actively Recruiting
Neoadjuvant Dupilumab, Pembrolizumab, Paclitaxel, and Carboplatin in Locally Advanced Triple Negative Breast Cancer
Led by Rima Patel · Updated on 2026-05-14
15
Participants Needed
1
Research Sites
105 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Neoadjuvant Dupilumab, Pembrolizumab, Paclitaxel, and Carboplatin in Locally Advanced Triple Negative Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with confirmed triple negative breast cancer as defined by ASCO/CAP guidelines
- Previously untreated localized TNBC with tumor size �3e= 2 cm or lymph node involvement with at least 1 cm tumor
- No prior breast surgery, radiation, or systemic chemotherapy with therapeutic intent for this cancer
- Eligible to receive paclitaxel and carboplatin chemotherapy
- Willing and able to provide blood samples as scheduled
- Willing and able to have core needle tumor biopsies before treatment
- Age 18 years or older
- ECOG performance status 0 or 1
- Adequate organ and marrow function including specified blood counts and liver/kidney tests within normal limits
- Women of child-bearing potential and men must agree to use effective contraception during and for 6 months after study
- Ability to understand and sign informed consent
You will not qualify if you...
- Prior chemotherapy or radiotherapy within 4 weeks before study entry or any prior breast cancer treatment with therapeutic intent
- Receiving other investigational agents
- Presence of distant metastases (Stage IV disease)
- Diagnosis of immunodeficiency or recent systemic steroid or immunosuppressive therapy within 7 days before study treatment
- Active autoimmune disease requiring systemic treatment in past year
- Conditions or therapies that may interfere with study or pose risk as judged by investigator
- Allergic reactions to study drugs or similar compounds
- HIV positive with detectable viral load or unstable antiviral treatment
- Active Hepatitis B or C infection unless controlled on therapy
- Untreated helminth infections
- History of bone marrow or organ transplantation
- Receipt of live vaccine within 30 days before study drug
- Previous immune-related adverse events from immunotherapy not resolved to Grade 0 or 1
- History of interstitial lung disease or immune-related pneumonitis requiring steroids
- Uncontrolled illnesses including active infections, heart conditions, arrhythmias, or psychiatric/social situations limiting study compliance
- Pregnant or nursing women due to potential risks to fetus or infant
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Mount Sinai Health System
New York, New York, United States, 10029
Actively Recruiting
Research Team
R
Rima Patel, MD
CONTACT
K
Katherine Vandris
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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