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Cancer Vaccine

Cancer Vaccine for Breast Cancer

Phase 1
Waitlist Available
Led By Mary Disis
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients who have completed standard of care and recovered with mild to no residual toxicity from recent therapy
Patients with stage III-IV HER2 negative breast cancer treated with primary or salvage therapy and now have: No evidence of disease (NED), or Stable bone only disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial is studying a vaccine made from DNA to see if it can help treat patients with HER2-negative stage III-IV breast cancer by targeting proteins that are expressed in cancer stem cells.

Who is the study for?
This trial is for adults with HER2-negative stage III-IV breast cancer who have completed standard treatments and are not currently pregnant or breastfeeding. They should have a life expectancy over 6 months, normal organ function tests, no recent major illnesses or surgeries, and agree to use contraception. Those with autoimmune diseases, seizure disorders, significant heart conditions, or on other treatment studies can't join.Check my eligibility
What is being tested?
The trial is testing a new DNA vaccine targeting proteins in breast cancer stem cells that resist chemotherapy and spread the disease. It aims to teach the body's immune system to destroy these tumor cells. The study will determine the safest dose of this vaccine while monitoring its effects through lab analysis.See study design
What are the potential side effects?
Potential side effects include reactions at the injection site like pain or swelling, flu-like symptoms such as fever and chills, fatigue, headache, muscle pain. Since it's an early-phase trial assessing safety and dosage levels (phase I), detailed side effect profiles will be studied.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I've finished my standard treatment and have little to no side effects.
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I have stage III-IV HER2 negative breast cancer with no signs of the disease or only stable bone disease.
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I am currently taking bisphosphonates, denosumab, or hormone therapy.
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My kidney function is normal, based on recent tests.
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It's been over 28 days since my last chemotherapy or antibody therapy.
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I am fully active or can carry out light work.
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I haven't taken any steroids for at least 28 days.
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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.

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
Immunologic efficacy defined as achievement of a statistically significant increase in Th1 cell immunity for at least 50% of the immunizing antigens as compared to baseline
Incidence of toxicity per Cancer Therapy Evaluation Program Common Terminology Criteria for Adverse Events version 4.0
Secondary outcome measures
Bac-TA cross-reactive T-cells
Memory Th1 dominant immune response to all five antigens over time
Modulation of MDSC with vaccination
+2 more

Side effects data

From 2012 Phase 3 trial • 6104 Patients • NCT01346592
27%
Injection site pain
25%
Pyrexia
14%
Upper respiratory tract infection
14%
Decreased appetite
14%
Diarrhea
10%
Injection site erythema
9%
Nasopharyngitis
9%
Irritability postvaccinal
9%
Headache
8%
Vomiting
8%
Injection site induration
7%
Hypersomnia
7%
Myalgia
7%
Injection site swelling
7%
Fatigue
6%
Crying
6%
Injection site hemorrhage
4%
Gastroenteritis
1%
Pneumonia
1%
Animal Bite
100%
80%
60%
40%
20%
0%
Study treatment Arm
ATIV (6 to <72 Months)
TIV (6 to <72 Months)
Comparator TIV (6 to <72 Months)

Trial Design

4Treatment groups
Experimental Treatment
Group I: Arm 4 (STEMVAC)Experimental Treatment2 Interventions
Patients receive CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope plasmid DNA vaccine with rhuGM-CSF as 2 injections ID every 28 days for 3 months. Patients may also receive 1 additional STEMVAC vaccine at 3 months after the third vaccine in the absence of unacceptable toxicity or disease progression.
Group II: Arm 3 (STEMVAC)Experimental Treatment2 Interventions
Patients receive CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope plasmid DNA vaccine with rhuGM-CSF as 3 injections ID every 28 days for 3 months. Patients may also receive 2 additional booster STEMVAC vaccines at 3 and 9 months after the third vaccine in the absence of unacceptable toxicity or disease progression.
Group III: Arm 2 (STEMVAC)Experimental Treatment2 Interventions
Patients receive CD105/Yb-1/SOX2/CDH3/M2-polyepitope plasmid DNA vaccine with rhuGM-CSF as 2 injections ID every 28 days for 3 months. Patients may also receive 2 additional booster STEMVAC vaccines at 3 and 9 months after the third vaccine in the absence of unacceptable toxicity or disease progression.
Group IV: Arm 1 (STEMVAC)Experimental Treatment2 Interventions
Patients receive CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope plasmid DNA vaccine with rhuGM-CSF as 1 injection ID every 28 days for 3 months. Patients may also receive 2 additional booster STEMVAC vaccines at 3 and 9 months after the third vaccine in the absence of unacceptable toxicity or disease progression.

Find a Location

Who is running the clinical trial?

Breast Cancer AllianceUNKNOWN
1 Previous Clinical Trials
60 Total Patients Enrolled
University of WashingtonLead Sponsor
1,726 Previous Clinical Trials
1,821,275 Total Patients Enrolled
20 Trials studying Breast Cancer
3,253 Patients Enrolled for Breast Cancer
United States Department of DefenseFED
856 Previous Clinical Trials
225,553 Total Patients Enrolled
37 Trials studying Breast Cancer
3,466 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: NCT02157051 — Phase 1
Breast Cancer Research Study Groups: Arm 2 (STEMVAC), Arm 3 (STEMVAC), Arm 4 (STEMVAC), Arm 1 (STEMVAC)
Breast Cancer Clinical Trial 2023: CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine Highlights & Side Effects. Trial Name: NCT02157051 — Phase 1
CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine (Cancer Vaccine) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02157051 — Phase 1

Frequently Asked Questions

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

Is there an ongoing recruitment process for participants in this clinical experiment?

"The information hosted on clinicaltrials.gov reveals that this research is no longer actively recruiting participants, having last been updated on September 23rd 2022. Though it is not open for enrollment anymore, there are currently 4569 other medical trials available to patients."

Answered by AI

Has the FDA approved the CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine?

"The safety of CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine is tentatively rated a 1, due to limited evidence supporting its efficacy and safety in clinical trials."

Answered by AI
~4 spots leftby Mar 2025