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ACTIVE NOT RECRUITING
NCT04270149
PHASE1

Cancer Peptides Plus GM-CSF and Adjuvant in Breast Cancer

Sponsor: Herbert Lyerly

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

8

Start Date

2020-09-01

Completion Date

2027-08-01

Last Updated

2026-02-27

Healthy Volunteers

No

Conditions

Interventions

BIOLOGICAL

ESR1 peptide vaccine

ESR1 peptides plus Montanide and GM-CSF

Locations (1)

Duke University Medical Center

Durham, North Carolina, United States