Cancer Peptides Plus GM-CSF and Adjuvant in Breast Cancer

ClinicalTrials.gov ID: NCT04270149

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Official title

A Phase I Study of Cancer Peptides Plus GM-CSF and Adjuvant Following Completion of Prescribed Systemic Therapy of Estrogen Receptor Positive Breast Cancer

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT04270149
Recruitment status: Active, not recruiting
Study type: Interventional
Phase: Phase 1
Lead sponsor: Herbert Lyerly; Other
Enrollment: 8 participants

Conditions and interventions

Conditions

Breast Cancer

Interventions

ESR1 peptide vaccine Biological

Biological

Eligibility (public fields only)

Age range: 18 Years and older
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Sep 1, 2020 (Actual)
Primary completion: May 30, 2025 (Actual)
Completion: Aug 1, 2027 (Estimated)
Last update posted: Nov 12, 2026

2020 – 2027

United States locations

U.S. sites: 1
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
Duke University Medical Center	Durham	North Carolina	27710	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT04270149, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Nov 12, 2026 · Synced Nov 13, 2026