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NCT04427293 · ClinicalTrials.gov registry record · Phase 1

Preoperative Lenvatinib Plus Pembrolizumab in Early-Stage Triple-Negative Breast Cancer (TNBC)

A Phase 1 study of Triple Negative Breast Cancer, sponsored by University of Illinois at Chicago.

Recruiting
Registry status
Phase 1
Development phase
12
Enrollment target
1
Study location

NCT04427293: Recruiting Phase 1 study of Triple Negative Breast Cancer, sponsored by University of Illinois at Chicago.

NCT04427293 is a Phase 1 study of Triple Negative Breast Cancer that is actively recruiting participants, run by University of Illinois at Chicago. The registered enrollment target is 12 participants, below the 246-participant average among 118 other Triple Negative Breast Cancer trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04427293, a Phase 1 study of Triple Negative Breast Cancer, is actively recruiting participants, sponsored by University of Illinois at Chicago.

RECRUITING
Registry status
Phase 1
Development phase
12 participants
Enrollment target
1
Study location

Study Summary

This is single arm study of a window of opportunity in which participants with previously untreated triple negative breast cancers (TNBC) who are candidates for potentially curative surgery will receive lenvatinib 12 mg daily for 7 and pembrolizumab 200 mg IV on day 1 prior to surgery

Primary Outcome

Measuring the presence of a T-cell inflamed TME, characterized by infiltration of CD8+ TILs

Interventions

  • DRUG Pembrolizumab
  • DRUG Lenvatinib

Study Locations (1)

Illinois

  • University of Illinois - Chicago

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2020-07-09
Est. Completion 2026-07
Phase Phase 1
University of Illinois at Chicago

430 total trials

What NCT04427293 shows while recruiting

NCT04427293 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 246-participant average among 118 other Triple Negative Breast Cancer trials with a reported enrollment target (95% lower).

The record links to 1 condition, with Triple Negative Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.

NCT04427293 reports a single indexed study location in Illinois.

Frequently Asked Questions

What is clinical trial NCT04427293 about?

NCT04427293 is a clinical study titled "Preoperative Lenvatinib Plus Pembrolizumab in Early-Stage Triple-Negative Breast Cancer (TNBC)". This is single arm study of a window of opportunity in which participants with previously untreated triple negative breast cancers (TNBC) who are candidates for potentially curative surgery will receive lenvatinib 12 mg daily for 7 and pembrolizumab 200 mg IV on day 1 prior to surgery

What is the current status of trial NCT04427293?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2020-07-09. Estimated completion is 2026-07.

What conditions does trial NCT04427293 study?

This clinical trial studies the following conditions: Triple Negative Breast Cancer.

What interventions are being tested in trial NCT04427293?

The interventions under investigation include: Pembrolizumab (DRUG), Lenvatinib (DRUG).

Who is sponsoring clinical trial NCT04427293?

This trial is sponsored by University of Illinois at Chicago, which has 430 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04427293 being conducted?

This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for 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 NCT04427293's enrollment target sits among peer trials

12 112th of 118 higher than 5 of 118 other Triple Negative Breast Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other 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

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Source: ClinicalTrials.gov NCT04427293, the US trial registry maintained by the National Library of Medicine. NCT04427293 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.