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NCT04331067 · ClinicalTrials.gov registry record · Phase 1

Neoadjuvant Nivolumab and Chemotherapy in Patients With Localized Triple-negative Breast Cancer

A Phase 1 study of Triple Negative Breast Cancer, sponsored by Washington University School of Medicine.

Active
Registry status
Phase 1
Development phase
15
Enrollment target
1
Study location

NCT04331067 is a Phase 1 study of Triple Negative Breast Cancer that is active but no longer recruiting, run by Washington University School of Medicine. The registered enrollment target is 15 participants, below the 246-participant average among 118 other Triple Negative Breast Cancer trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04331067, a Phase 1 study of Triple Negative Breast Cancer, is active but no longer recruiting, sponsored by Washington University School of Medicine.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
15 participants
Enrollment target
1
Study location

Study Summary

Prior to Amendment #7: The hypothesis of this study is that the combination of cabiralizumab and nivolumab with neoadjuvant chemotherapy will decrease tumor associated macrophages (TAMs) and increase tumor infiltrating lymphocytes (TIL) compared to neoadjuvant chemotherapy plus nivolumab in patients with early stage triple-negative breast cancer (TNBC) and improve clinical outcomes. As of Amendment #7 IRB approved 10/13/2022: The study will no longer enroll to Arm B. Cabiralizumab will no longer be given. The hypothesis of this study is that on-treatment tumor associated macrophages (TAMs) and tumor infiltrating lymphocytes (TILs) will improve (reduced TAMs, increased TILs) following neoadjuvant nivolumab with chemotherapy.

Conditions Studied

Triple Negative Breast Cancer

Interventions

  • DRUG Carboplatin
  • DRUG Paclitaxel
  • BIOLOGICAL Nivolumab
  • PROCEDURE Tumor biopsy
  • BIOLOGICAL Cabiralizumab

Study Locations (1)

Missouri

  • Washington University School of Medicine - St Louis

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2020-11-19
Est. Completion 2026-05-31
Phase Phase 1

Sponsor

Washington University School of Medicine

1,502 total trials

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What the Registry Record Tells You About NCT04331067

The ClinicalTrials.gov registry entry for NCT04331067 describes a study currently listed as active not recruiting, categorized as 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 246-participant average among 118 other Triple Negative Breast Cancer trials with a reported enrollment target (94% lower). The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Triple Negative Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.

NCT04331067 reports 1 study location spanning 1 distinct geographic area - top geographies include Missouri.

Frequently Asked Questions

What is clinical trial NCT04331067 about?

NCT04331067 is a clinical study titled "Neoadjuvant Nivolumab and Chemotherapy in Patients With Localized Triple-negative Breast Cancer". Prior to Amendment #7: The hypothesis of this study is that the combination of cabiralizumab and nivolumab with neoadjuvant chemotherapy will decrease tumor associated macrophages (TAMs) and increase tumor infiltrating lymphocytes (TIL) compared to neoadjuvant chemotherapy plus nivolumab in patients...

What is the current status of trial NCT04331067?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2020-11-19. Estimated completion is 2026-05-31.

What conditions does trial NCT04331067 study?

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

What interventions are being tested in trial NCT04331067?

The interventions under investigation include: Carboplatin (DRUG), Paclitaxel (DRUG), Nivolumab (BIOLOGICAL), Tumor biopsy (PROCEDURE), Cabiralizumab (BIOLOGICAL).

Who is sponsoring clinical trial NCT04331067?

This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04331067 being conducted?

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

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.