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Nelipepimut-S Plus GM-CSF Vaccine Therapy in Treating Patients With Breast Cancer

NCT02636582 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2023-12-05

Study results available
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Summary

This phase II trial studies how well nelipepimut-S plus GM-CSF vaccine therapy or sargramostim works in treating patients with breast cancer. Vaccines made from peptide or antigen and/or a person's white blood cells mixed with tumor proteins may help the body build an effective immune response to kill tumor cells that express breast cancer antigens. It is not yet known whether nelipepimut-S plus GM-CSF vaccine or sargramostim is more effective in treating patients with breast cancer.

Conditions

  • Breast Ductal Carcinoma In Situ

Interventions

OTHER

Laboratory Biomarker Analysis

Correlative studies

DRUG

Nelipepimut-S Plus GM-CSF Vaccine

Given ID

BIOLOGICAL

Sargramostim

Given ID

PROCEDURE

Surgical Procedure

Undergo surgery

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Powel H Brown · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-14
Primary Completion
2019-07-22
Completion
2023-05-17

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02636582 on ClinicalTrials.gov