What side effects are associated with this type of intervention?

Common treatments for breast cancer, particularly those involving immunotherapy and endocrine therapy, have a range of side effects. Immunotherapy can cause chills, fatigue, fever, back pain, nausea, joint ache, and headache, with serious adverse events like infusion reactions and cerebrovascular events being less common. Endocrine therapies, such as tamoxifen and aromatase inhibitors, may lead to hot flashes, vaginal dryness, mood swings, and increased risks of blood clots and bone density loss.

What prior FDA approvals exist?

The FDA has approved several immunotherapy drugs for the treatment of breast cancer, particularly for HER2-negative subtypes. Pembrolizumab, an immune checkpoint inhibitor targeting PD-1, has been approved for use in combination with chemotherapy for triple-negative breast cancer. Additionally, atezolizumab, another checkpoint inhibitor targeting PD-L1, has been approved for similar indications. These treatments work by stimulating the body's immune response to target and kill tumor cells, akin to the mechanism being studied in the DNA vaccine trial.

What other types of research exist?

Promising novel alternatives to DNA vaccines for breast cancer patients in 2024 include: 1) Immune checkpoint inhibitors such as pembrolizumab and dostarlimab, which target PD-1/PD-L1 pathways to enhance the immune response against tumor cells. 2) CAR-T cell therapy, which involves engineering a patient's T cells to better recognize and attack cancer cells. 3) Personalized cancer vaccines that use neoantigens specific to an individual's tumor to stimulate a targeted immune response. 4) Combination therapies that integrate immunotherapy with traditional treatments like chemotherapy or radiation to improve overall efficacy.

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Cancer Vaccine

Cancer Vaccine for Breast Cancer Remission (WOKVAC Trial)

Q: What is the mechanism of action of this treatment?

Common treatments for breast cancer that stimulate the immune response include immunotherapy and targeted therapy. Immunotherapy, such as checkpoint inhibitors, works by enhancing the body's immune system to recognize and attack cancer cells. Targeted therapies, like HER2 inhibitors, specifically target cancer cell proteins that promote tumor growth. The DNA vaccine being studied aims to stimulate an immune response to kill tumor cells by using DNA to produce antigens that trigger the immune system. These treatments are crucial for breast cancer patients as they offer more personalized and potentially less toxic options compared to traditional chemotherapy, improving outcomes and quality of life.

Phase 1

Waitlist Available

Led By Kari Wisinski

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 non-metastatic, node positive, HER2 negative breast cancer, confirmed by pathology report, who are in remission and defined as having no evidence of disease (NED)

Patients must have Eastern Cooperative Oncology Group (ECOG) performance status score of =< 2

Must not have

Patients with any of the following cardiac conditions: Symptomatic restrictive cardiomyopathy, Dilated cardiomyopathy, Unstable angina within 4 months prior to enrollment, New York Heart Association functional class III-IV heart failure on active treatment, Symptomatic pericardial effusion

Patients with any contraindication or known hypersensitivity to receiving sargramostatin (recombinant human granulocyte macrophage colony stimulating factor [rhuGM-CSF]) or other yeast based products

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 9 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a DNA vaccine called WOKVAC in patients with a specific type of breast cancer to see if it can help prevent the cancer from returning by boosting the immune system.

Who is the study for?

This trial is for patients with non-metastatic, node-positive, HER2 negative breast cancer in remission. Participants must have stable health without major recent surgeries or infections and agree to use contraception if applicable. They should not be on other investigational drugs, have certain heart conditions, allergies to similar vaccines or yeast products, uncontrolled autoimmunity, diabetes, or known HIV/hepatitis B/C.

What is being tested?

The trial tests a DNA vaccine's safety and optimal dosage designed to prevent breast cancer recurrence by strengthening the immune response against tumor cells. It involves multiple vaccinations and includes laboratory biomarker analysis alongside the administration of Sargramostim and pUMVC3-IGFBP2-HER2-IGF1R Plasmid DNA Vaccine.

What are the potential side effects?

Potential side effects may include typical vaccine reactions such as soreness at injection site, fever, fatigue; allergic responses; autoimmune reactions where the body attacks its own cells; plus any specific issues related to sargramostim like bone pain or weakness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My breast cancer is not spread, HER2 negative, in remission, and shows no signs of disease.

Select...

I can take care of myself but might not be able to do heavy physical work.

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My kidney function is normal or only slightly impaired.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have serious heart conditions, including unstable chest pain or heart failure.

Select...

I am not allergic to sargramostatin or yeast-based products.

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I have a history of diabetes.

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I have a history of HIV, hepatitis B, or hepatitis C.

Select...

My autoimmune disease has not been under control despite treatment in the past year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 9 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 9 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 9 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Adverse Events Per Common Terminology Criteria for Adverse Events Version 4.0

Secondary study objectives

Assessment of IgG Antibodies

Assessment of T Helper Th1:Th2 Ratio

Assessment of the Immunogenicity of WOKVAC by Generation of IGFBP-2, HER2, and IGF-1R Specific Type 1 (Th1) T- Cells

+3 more

Other study objectives

Change in mammographic density assessed using clinically available images and the automated Cumulus software program

Side effects data

From 2022 Phase 1 trial • 32 Patients • NCT02780401

90%

Injection site reaction

70%

Hypertension

70%

Lymphocyte count decreased

60%

Nausea

50%

Fatigue

50%

Flu like symptoms

50%

Myalgia

50%

White blood cell decreased

40%

Chills

40%

Headache

40%

Hypokalemia

40%

Cough

40%

Postnasal drip

30%

Non-cardiac chest pain

30%

Constipation

20%

Alkaline phosphatase increased

20%

Flushing

20%

Hypothyroidism

20%

Abdominal pain

20%

Arthralgia

20%

Diarrhea

20%

Surgical and medical procedures - Other

20%

Upper respiratory infection

10%

Hypotension

10%

Hyponatremia

10%

Muscle weakness lower limb

10%

Glucose

10%

Bloating

10%

Anxiety

10%

Aspartate aminotransferase increased

10%

Hypoxia

10%

Chest wall pain

10%

Alanine aminotransferase increased

10%

Dyspnea

10%

Breast pain

10%

Hyperthyroidism

10%

Investigations - Other

10%

Erythema multiforme

10%

Hypocalcemia

10%

Lymphedema

10%

Neutrophil count decreased

10%

Oral dysesthesia

10%

Phantom pain

10%

Renal calculi

10%

Respiratory, thoracic and mediastinal disorders - Other

10%

Skin and subcutaneous tissue disorders - Other

10%

Somnolence

10%

Sore throat

10%

Urinary tract infection (UTI)

10%

Vomiting

100%

80%

60%

40%

20%

Study treatment Arm

Treatment (WOKVAC With Sargramostim) - Dose 150 mcg + 100 mcg Sargramostim

Treatment (WOKVAC With Sargramostim) - Dose 600 mcg + 100 mcg Sargramostim

Treatment (WOKVAC With Sargramostim) - Dose 300 mcg + 100 mcg Sargramostim

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (WOKVAC with sargramostim)Experimental Treatment3 Interventions

Patients receive WOKVAC with sargramostim ID on day 1. Courses repeat every 28 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients with ALND will have vaccine administered to the contralateral arm. Patients with bilateral ALND will have vaccine administered in the thigh. As much as possible each vaccine dose will be given within the same draining lymph node site. Patients will be monitored for a minimum of 60 minutes post vaccine administration.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sargramostim

2006

Completed Phase 4

~880

pUMVC3-IGFBP2-HER2-IGF1R Plasmid DNA Vaccine

2016

Completed Phase 1

~40

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for breast cancer that stimulate the immune response include immunotherapy and targeted therapy. Immunotherapy, such as checkpoint inhibitors, works by enhancing the body's immune system to recognize and attack cancer cells. Targeted therapies, like HER2 inhibitors, specifically target cancer cell proteins that promote tumor growth. The DNA vaccine being studied aims to stimulate an immune response to kill tumor cells by using DNA to produce antigens that trigger the immune system. These treatments are crucial for breast cancer patients as they offer more personalized and potentially less toxic options compared to traditional chemotherapy, improving outcomes and quality of life.