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

Part of paid clinical trials in New York, New York.

Sponsor
Rima Patel
Study ID
NCT06637306
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dupilumab — DRUG
    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.
  • Pembrolizumab — DRUG
    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).
  • Paclitaxel — DRUG
    Paclitaxel 80mg/m2 intravenous weekly for 12 weeks. Chemotherapy FDA-approved for the treatment of patients with breast cancer.
  • Carboplatin — DRUG
    Carboplatin AUC 1.5 intravenous weekly for 12 weeks. Chemotherapy FDA-approved for the treatment of patients with breast cancer.

Study Details

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.

Key Dates

Start date
Mar 5, 2025
Status verified
May 2026
Primary completion
Mar 10, 2027
Completion
Mar 10, 2027

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Patients with locally advanced TNBC
    Patients with advanced triple negative breast cancer (TNBC).

Primary Outcome Measure

Incidence of severe immune-related adverse events (irSAE) [ Time Frame: Within 4 months of therapy ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mount Sinai Health SystemNew YorkNew York10029
Katherine Vandris
[email protected]
Rima Patel (PRINCIPAL_INVESTIGATOR)

Find similar trials in New York, NY

By research site
Mount Sinai Health System· New York, NY

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