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NCT04270149 · ClinicalTrials.gov registry record · Phase 1

Cancer Peptides Plus GM-CSF and Adjuvant in Breast Cancer

A Phase 1 study of Breast Cancer, sponsored by Herbert Lyerly.

Active
Registry status
Phase 1
Development phase
8
Enrollment target
1
Study location

NCT04270149 is a Phase 1 study of Breast Cancer that is active but no longer recruiting, run by Herbert Lyerly. The registered enrollment target is 8 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04270149, a Phase 1 study of Breast Cancer, is active but no longer recruiting, sponsored by Herbert Lyerly.

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

Study Summary

This is a phase I study looking at the safety of cancer peptides combined with adjuvant and GM-CSF in subjects with estrogen receptor (ESR) positive breast cancer. The primary objective of the study is to determine the safety of of the peptide vaccine. The secondary objective is to evaluate the immune response to the vaccine. The peptides used in this vaccine are derived from the estrogen receptor and are combined with the adjuvant Montanide ISA and GM-CSF to enhance their immune response. A peptide vaccine of these peptides may improve outcomes of patients with endocrine resistant breast cancer.

Conditions Studied

Interventions

  • BIOLOGICAL ESR1 peptide vaccine

Study Locations (1)

North Carolina

  • Duke University Medical Center - Durham

Trial Details

FieldValue
Enrollment Target 8 participants
Start Date 2020-09-01
Est. Completion 2027-08-01
Phase Phase 1

Sponsor

Herbert Lyerly

4 total trials

What the Registry Record Tells You About NCT04270149

The ClinicalTrials.gov registry entry for NCT04270149 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (100% lower). The listed sponsor is Herbert Lyerly, which has 4 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which ESR1 peptide vaccine is the first listed.

NCT04270149 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.

Frequently Asked Questions

What is clinical trial NCT04270149 about?

NCT04270149 is a clinical study titled "Cancer Peptides Plus GM-CSF and Adjuvant in Breast Cancer". This is a phase I study looking at the safety of cancer peptides combined with adjuvant and GM-CSF in subjects with estrogen receptor (ESR) positive breast cancer. The primary objective of the study is to determine the safety of of the peptide vaccine. The secondary objective is to evaluate the immu...

What is the current status of trial NCT04270149?

This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2020-09-01. Estimated completion is 2027-08-01.

What conditions does trial NCT04270149 study?

This clinical trial studies the following conditions: Breast Cancer.

What interventions are being tested in trial NCT04270149?

The interventions under investigation include: ESR1 peptide vaccine (BIOLOGICAL).

Who is sponsoring clinical trial NCT04270149?

This trial is sponsored by Herbert Lyerly, which has 4 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04270149 being conducted?

This trial has 1 study location across North Carolina. 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.