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STEMVAC in Patients With Early Stage Triple Negative Breast Cancer | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

STEMVAC in Patients With Early Stage Triple Negative Breast Cancer

A Phase II Trial of The Immunogenicity of a DNA Plasmid Based Vaccine (STEMVAC) Encoding Th1 Selective Epitopes From Five Antigens Associated With Breast Cancer Stem Cells (MDM2, YB1, SOX2, CDC25B, CD105) in Participants With Early Stage Triple Negative Breast Cancer

NCT05455658•University of Washington

View on ClinicalTrials.gov

Summary

This phase II trial studies the effect of DNA plasmid based vaccine (STEMVAC) in treating patients with patients with stage IB-III triple negative breast cancer. STEMVAC may wake up the immune system in patients who have had a diagnosis of triple negative breast cancer and have been treated. STEMVAC targets proteins that are expressed on breast cancer cells and works by boosting the immune system to recognize and destroy the invader cancer cell proteins that are causing the disease. The purpose of this trial is to test the immune system's response to STEMVAC.

Detailed Description

OUTLINE: Patients receive STEMVAC vaccine with sargramostim intradermally (ID) every month for 3 months in the absence of disease progression or unacceptable toxicity. Patients then receive STEMVAC vaccine with sargramostim ID booster injections 3 months after the 3rd vaccination and 6 months after the 1st booster vaccination. After completion of study treatment, patients are followed up at 28 days, and then annually for 5 years.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Participants with triple negative breast cancer, stages IB, II or III. Estrogen receptor (ER)-negative and progesterone receptor (PR)-negative is defined as breast cancer with less than 10% of ER or PR expression. HER2 negative is defined as:
•* 0-1+ HER2 expression by immunohistochemistry (IHC) OR
•* Fluorescence in situ hybridization (FISH) negative OR
•* HER2 2+ and FISH negative
•* Note: Participants with low ER positivity (≤10%) who are already on adjuvant hormonal therapy will be allowed on study and can continue their adjuvant hormonal treatment during study participation.
•Participants must have completed all standard of care (or investigational) systemic therapy (including immune modulating agents) and radiotherapy if used between 28 and 365 days prior to enrollment
•\* Note: Treatment with a bisphosphonate or denosumab to prevent bone loss is not considered to be systemic therapy for breast cancer and its use within the 28 day pre-enrollment period or while on study is not exclusionary. Treatment with adjuvant olaparib within the 28 day pre-enrollment period or while on study is not exclusionary.
•Participants must agree to avoid systemic steroids for the duration of the treatment period and until completion of the 1 month post 2nd booster vaccine visit (end of treatment)
•Participants must be at least 18 years of age
•\* Note: Because no dosing or adverse event (AE) data are currently available on the use of STEMVAC in participants \< 18 years of age, children and adolescents are excluded from this study but will be eligible for future pediatric trials, if applicable.
+16 more criteria

Exclusion Criteria

•Contraindication or known hypersensitivity to receiving sargramostim (rhuGM-CSF) or other products
•History of allergic reactions attributed to compounds of similar chemical or biologic composition to STEMVAC
•Participants receiving any other investigational agents
•Chronic use of nonsteroidal anti-inflammatory drugs (NSAIDs) is prohibited during the treatment period of the study, except when taken as low-dose (81 mg) aspirin therapy. Prohibited chronic use is defined as daily use for more than 7 days
•Participants with any clinically significant autoimmune disease uncontrolled with treatment
•Uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements
•Pregnant and breastfeeding women are excluded from this study
•Known history of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C
•\* Note: These individuals are excluded in order to avoid confounding an existing condition with an immune response to STEMVAC
•Chronic usage of immunosuppressants and glucocorticoids (methotrexate for RA, etc.)
+1 more criteria

Locations (3)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, United States

Key Dates

Start Date

November 17, 2022

Primary Completion Date

July 16, 2026

Completion Date

July 16, 2028

Last Updated

October 24, 2025

Enrollment

ACTUAL participants

Conditions

Anatomic Stage IB Breast Cancer AJCC v8Anatomic Stage II Breast Cancer AJCC v8Anatomic Stage IIA Breast Cancer AJCC v8Anatomic Stage IIB Breast Cancer AJCC v8Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IIIA Breast Cancer AJCC v8Anatomic Stage IIIB Breast Cancer AJCC v8Anatomic Stage IIIC Breast Cancer AJCC v8Prognostic Stage IB Breast Cancer AJCC v8Prognostic Stage II Breast Cancer AJCC v8Prognostic Stage IIA Breast Cancer AJCC v8Prognostic Stage IIB Breast Cancer AJCC v8Prognostic Stage III Breast Cancer AJCC v8Prognostic Stage IIIA Breast Cancer AJCC v8Prognostic Stage IIIB Breast Cancer AJCC v8Prognostic Stage IIIC Breast Cancer AJCC v8Triple-Negative Breast Carcinoma

Interventions

CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine

BIOLOGICAL

Sargramostim

BIOLOGICAL

Enhancing Skin Appearance and Quality of Life in Breast Cancer Survivors on Aromatase Inhibitor Therapy

NCT06401889

Anatomic Stage 0 Breast Cancer AJCC v8Anatomic Stage I Breast Cancer AJCC v8+5 more

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RECRUITINGPHASE1

An Optimized Ultrasound Twinkling Marker for the Imaging of Lymph Nodes in Patients With Clinically Node-Positive Breast Cancer, The UTMOST2 Trial

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Anatomic Stage II Breast Cancer AJCC v8Anatomic Stage III Breast Cancer AJCC v8+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 24, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

STEMVAC in Patients With Early Stage Triple Negative Breast Cancer

Inclusion Criteria

Exclusion Criteria

Enhancing Skin Appearance and Quality of Life in Breast Cancer Survivors on Aromatase Inhibitor Therapy

An Optimized Ultrasound Twinkling Marker for the Imaging of Lymph Nodes in Patients With Clinically Node-Positive Breast Cancer, The UTMOST2 Trial

Personalized Vaccine Immunotherapy in Combination With Checkpoint Inhibitor for Treatment of Triple Negative Breast Cancer

Metformin for the Treatment of Insulin Resistance in Women With Stage I-III Breast Cancer Completing Chemotherapy

Neurotization of the Nipple Areolar Complex to Restore Sensation for Patients With Breast Cancer Undergoing Nipple Sparing Mastectomy and Reconstruction

Breast Cancer Survivorship Biorepository