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NCT06637306

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

Recruiting now EARLY_PHASE1 Last updated 26 March 2025
What this trial tests

EARLY_PHASE1 trial testing Dupilumab in Locally Advanced Triple Negative Breast Cancer in 15 participants. Currently enrolling.

Timeline
5 March 2025
Primary endpoint
31 December 2026
1 June 2027

Quick facts

Lead sponsorRima Patel
PhaseEARLY_PHASE1
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment15
Start date5 March 2025
Primary completion31 December 2026
Estimated completion1 June 2027
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Rima Patel

Who can join

18 and older, any sex, with Locally Advanced Triple Negative Breast Cancer or TNBC - Triple-Negative Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Tumor secretome shapes the immune landscape during cancer progression.
    Yang J, Tang S, Saba NF, Shay C, et al · · 2025 · cited 16× · PMID 39930476 · DOI 10.1186/s13046-025-03302-0
  2. Recent Advances in Immune Checkpoint Inhibitors for Triple-Negative Breast Cancer.
    Corti C, Koca B, Rahman T, Mittendorf EA, et al · · 2025 · cited 11× · PMID 40196378 · DOI 10.2147/itt.s495751
  3. Steroid-sparing strategies for managing immune-related adverse events.
    Huang JJ, YousefiAsl M, Singh N, Grivas P, et al · · 2026 · cited 1× · PMID 41545303 · DOI 10.1136/jitc-2025-013776
  4. Tumor-infiltrating lymphocytes and tumor-associated macrophages in cancer immunoediting: a targetable therapeutic axis.
    Mukherjee S, Ghosh A, Chakraborty S, Basak U, et al · · 2025 · PMID 41019045 · DOI 10.3389/fimmu.2025.1655176

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