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Cancer Vaccine

Cancer Vaccine for Triple Negative Breast Cancer

Phase 2
Recruiting
Led By Mary Disis, MD
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Serum creatinine =< 1.2 mg/dl OR creatinine clearance > 60 ml/min (within 60 days of enrollment and at least 28 days post standard of care [SOC] treatment)
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 1% 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial is testing a vaccine for triple negative breast cancer. The vaccine is designed to wake up the immune system to help it recognize and destroy cancer cells.

Who is the study for?
This trial is for adults with stage IB-III triple negative breast cancer who have finished standard treatments between 28 and 365 days before joining. They must be in good health, not pregnant or breastfeeding, agree to use contraception, and not have HIV, hepatitis B/C, severe allergies to the vaccine components or yeast-based products. Participants can't take chronic NSAIDs except low-dose aspirin.Check my eligibility
What is being tested?
The trial tests STEMVAC, a DNA plasmid-based vaccine designed to stimulate the immune system against proteins found on breast cancer cells. It's given alongside Sargramostim which may help boost the body's response to the vaccine.See study design
What are the potential side effects?
Possible side effects include reactions at the injection site like pain or swelling, flu-like symptoms such as fever and chills due to immune activation by STEMVAC and Sargramostim. Allergic reactions are also possible but less common.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My kidney function is normal, based on recent tests.
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My breast cancer is triple negative and in stage IB, II, or III.
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I finished my standard cancer treatment, including immunotherapy and radiotherapy, between 28 and 365 days ago.
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I agree not to take systemic steroids until 1 month after my 2nd booster vaccine.
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My hemoglobin level is at least 10 mg/dl after recent treatments.
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I agree to use birth control during the study and for 1 month after, unless I cannot get pregnant due to surgery or menopause.
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I have recovered from major infections or surgeries and don't have other serious illnesses that would prevent me from following the treatment plan.
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I will inform my doctor immediately if I become or suspect I am pregnant during the study.
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My bilirubin levels are within normal range.
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I am fully active or can carry out light work.
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My platelet count is at least 100,000 and was tested within the last 60 days.
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I am a man willing to use contraception during the study.
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My lymphocyte count is at least 800 and was measured after my last treatment.
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I am 18 years old or older.
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I agree not to have major surgery until my treatment ends, except for port removal.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cellular immune response: incidence
Cellular immune response: magnitude
Secondary outcome measures
Activation status and repertoire diversity of peripheral blood T-cells
Incidence of adverse events
Kinetics of the magnitude of antigen specific IFN-gamma ELISPOT counts
+1 more

Side effects data

From 2021 Phase 4 trial • 87 Patients • NCT04326920
22%
Infectious disorder (not COVID-19)
15%
Constipation
7%
Cardiac disorder
5%
Epistaxis
2%
Pneumonia
2%
Thormboembolic event
2%
Aspergillus infection
2%
Respiratory failure
2%
Hypoxia
2%
Multi-bacterial bacteremia causing hemorrhagic shock
100%
80%
60%
40%
20%
0%
Study treatment Arm
Control Group
Active Sargramostim Treatment Group

Trial Design

1Treatment groups
Experimental Treatment
Group I: Prevention (STEMVAC vaccine, sargramostim)Experimental Treatment2 Interventions
Patients receive STEMVAC vaccine with sargramostim 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sargramostim
FDA approved

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor
1,732 Previous Clinical Trials
1,842,081 Total Patients Enrolled
20 Trials studying Breast Cancer
3,253 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,802 Total Patients Enrolled
939 Trials studying Breast Cancer
1,543,343 Patients Enrolled for Breast Cancer
University of Wisconsin, MadisonOTHER
1,177 Previous Clinical Trials
3,012,129 Total Patients Enrolled
36 Trials studying Breast Cancer
38,519 Patients Enrolled for Breast Cancer

Media Library

CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine (Cancer Vaccine) Clinical Trial Eligibility Overview. Trial Name: NCT05455658 — Phase 2
Breast Cancer Research Study Groups: Prevention (STEMVAC vaccine, sargramostim)
Breast Cancer Clinical Trial 2023: CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine Highlights & Side Effects. Trial Name: NCT05455658 — Phase 2
CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05455658 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many research participants will be included in this experiment?

"Yes, this clinical trial is currently recruiting patients. As of right now, 33 individuals are needed at 2 different locations. The study was first posted on December 1st, 2022 and has since been updated once on November 1st, 2022."

Answered by AI

Are there any current openings for patients who wish to participate in this clinical trial?

"The trial is currently looking for patients, as seen on clinicaltrials.gov. The original posting was on December 1st, 2022 and the most recent update was on November 1st, 2022."

Answered by AI

What does this research hope to uncover about the treatment?

"The purpose of this study is to assess the efficacy of a new immunotherapy treatment over a period of 10 months. The primary outcome measure will be the cellular immune response magnitude, and secondary outcomes include activation status and repertoire diversity of peripheral blood T-cells, as well as the kinetics of the magnitude of antigen specific IFN-gamma ELISPOT counts. Safety and incidence of adverse events will also be monitored throughout the study."

Answered by AI

Has Sargramostim been federally recognized as a safe and effective treatment?

"While there is some evidence to support its safety, Sargramostim did not receive a higher score because Phase 2 trials lack data demonstrating efficacy."

Answered by AI
~15 spots leftby Apr 2025