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NCT06637306 · ClinicalTrials.gov registry record · Early Phase 1
Neoadjuvant Dupilumab, Pembrolizumab, Paclitaxel, and Carboplatin in Locally Advanced Triple Negative Breast Cancer
A Early Phase 1 study of TNBC - Triple-Negative Breast Cancer and Locally Advanced Triple Negative Breast Cancer, sponsored by Rima Patel.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT06637306 is a Early Phase 1 study of TNBC - Triple-Negative Breast Cancer and Locally Advanced Triple Negative Breast Cancer that is actively recruiting participants, run by Rima Patel. The registered enrollment target is 15 participants, below the 481-participant average among 22 other TNBC - Triple-Negative Breast Cancer trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06637306, a Early Phase 1 study of TNBC - Triple-Negative Breast Cancer and Locally Advanced Triple Negative Breast Cancer, is actively recruiting participants, sponsored by Rima Patel.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study 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.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Carboplatin
- DRUG Dupilumab
- DRUG Paclitaxel
Study Locations (1)
New York
- Mount Sinai Health System - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2025-03-05 |
| Est. Completion | 2027-06-01 |
| Phase | Early Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06637306
The ClinicalTrials.gov registry entry for NCT06637306 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 481-participant average among 22 other TNBC - Triple-Negative Breast Cancer trials with a reported enrollment target (97% lower). The listed sponsor is Rima Patel, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with TNBC - Triple-Negative Breast Cancer appearing as the primary indexed condition, and to 4 interventions - of which Pembrolizumab is the first listed.
NCT06637306 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT06637306 about?
NCT06637306 is a clinical study titled "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 (TNBC). Primary Objective: To assess the safety of neoadjuvant dupilumab and pembrolizumab plus weekly paclitaxel and carboplatin as measured by th...
What is the current status of trial NCT06637306?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 15 participants. The study started on 2025-03-05. Estimated completion is 2027-06-01.
What conditions does trial NCT06637306 study?
This clinical trial studies the following conditions: TNBC - Triple-Negative Breast Cancer, Locally Advanced Triple Negative Breast Cancer.
What interventions are being tested in trial NCT06637306?
The interventions under investigation include: Pembrolizumab (DRUG), Carboplatin (DRUG), Dupilumab (DRUG), Paclitaxel (DRUG).
Who is sponsoring clinical trial NCT06637306?
This trial is sponsored by Rima Patel, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06637306 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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