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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 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
Patients must have Eastern Cooperative Oncology Group (ECOG) performance status score of =< 1
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 belowSelect...
I have stage III-IV HER2 negative breast cancer with no signs of the disease or only stable bone disease.
Select...
I am fully active or can carry out light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
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 moreSide effects data
From 2023 Phase 4 trial • 267 Patients • NCT050070418%
COVID-19 Infection
7%
Upper Respiratory Infection
1%
Cardiovascular Accident (CVA), Unspecified Mechanism
1%
Acute pulmonary embolism and acute deep vein thrombosis
1%
Left partial cranial nerve III palsy
1%
Acute Hyperkalemia
1%
Shortness of Breath
100%
80%
60%
40%
20%
0%
Study treatment Arm
Recombinant Zoster Vaccine (RZV) and High-Dose Quadrivalent Influenza Vaccine
Recombinant Zoster Vaccine (RZV) and Quadrivalent Adjuvanted Influenza Vaccine
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
1,749 Previous Clinical Trials
1,838,602 Total Patients Enrolled
20 Trials studying Breast Cancer
3,253 Patients Enrolled for Breast Cancer
United States Department of DefenseFED
867 Previous Clinical Trials
327,320 Total Patients Enrolled
38 Trials studying Breast Cancer
103,475 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I've finished my standard treatment and have little to no side effects.I have stage III-IV HER2 negative breast cancer with no signs of the disease or only stable bone disease.I have an autoimmune disease that isn't managed well, even with treatment.I am currently taking bisphosphonates, denosumab, or hormone therapy.I am at risk for stomach bleeding due to ulcers or long-term use of NSAIDs.I am allergic or cannot take rhuGM-CSF based products.My kidney function is normal, based on recent tests.It's been over 28 days since my last chemotherapy or antibody therapy.I have serious heart conditions, including unstable angina, severe heart failure, or fluid around the heart.Your lymphocyte count is at least 800 cells per cubic millimeter within 30 days before the first vaccination.Your platelet count needs to be at least 75,000 per cubic millimeter within 30 days before the first vaccination.I am fully active or can carry out light work.You are expected to live for more than 6 months.I haven't taken any steroids for at least 28 days.Your hemoglobin level needs to be 10 grams per deciliter or higher within 30 days of the first vaccination.I have recovered from major infections or surgeries and don't have other serious illnesses that would prevent me from following the treatment plan.Your total bilirubin level should be less than or equal to 1.5 mg/dl within 30 days before the first vaccination.Your AST/SGOT levels are not more than twice the normal limit within 30 days of the first vaccination.I have a condition that causes seizures.Your blood sugar level is less than 1.5 times the upper limit of normal within the past 30 days.Your white blood cell count must be at least 3000 per cubic millimeter within 30 days of the first vaccination.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 3 (STEMVAC)
- Group 2: Arm 4 (STEMVAC)
- Group 3: Arm 2 (STEMVAC)
- Group 4: Arm 1 (STEMVAC)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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