Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting Early Phase 1 study of TNBC - Triple-Negative Breast Cancer and Locally Advanced Triple Negative Breast Cancer, sponsored by Rima Patel.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Incidence of severe immune-related adverse events within 4 months of therapy. Immune related Severe Adverse Events (irSAE) are defined as: * Any Grade 4 immune-related AE with the exception of hypothyroidism * Any Grade 3 immune-related AE requiring permanent discontinuation of dupilumab and pembrolizumab * Any new Grade 3 or Grade 4 non-hematologic laboratory abnormality, if * medical intervention is required, or * the abnormality leads to hospitalization, or * the abnormality persists
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 |
What NCT06637306 shows while recruiting
NCT06637306 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 481-participant average among 22 other TNBC - Triple-Negative Breast Cancer trials with a reported enrollment target (97% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for TNBC - Triple-Negative Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06637306's enrollment target sits among peer trials
15 22nd of 22 the lowest of 22 other TNBC - Triple-Negative Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other TNBC - Triple-Negative Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Neoadjuvant Therapy and Contrast-enhanced Mammography for Early Stage Breast Cancer
RECRUITING · Early Phase 1
-
Adjuvant Therapy With an Alpha-lactalbumin Vaccine in Triple-Negative Breast Cancer
ACTIVE NOT RECRUITING · Early Phase 1
-
Phase II Trial of Ivonescimab in Combination With Carboplatin + Docetaxel in Patients With Early-Stage Triple Negative Breast Cancer
RECRUITING · Phase 2
-
Study of AVZO-021 in Patients With Advanced Solid Tumors
RECRUITING · Phase 1
-
A Study to Examine the Safety of Different Doses of BG-68501 Given to Participants With Advanced-Stage Tumors
RECRUITING · Phase 1
-
First in Human Study of TUB-030 in Patients With Advanced Solid Tumors
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01889381 · 15 participants · Phase 2
Human Craniomaxillofacial Allotransplantation
- NCT02530073 · 15 participants · NA
Trial of Fetoscopic Endoluminal Tracheal Occlusion (FETO) for CDH
- NCT02535936 · 15 participants · NA
Cortical Plasticity in Spastic Diplegia After Selective Dorsal Rhizotomy
- NCT02918474 · 15 participants · NA
Decision Making Tool in Supporting Decision Making in Contralateral Prophylactic Mastectomy in Patients With Newly Diagnosed Breast Cancer
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI