What side effects are associated with this type of intervention?

Common treatments for breast cancer, such as chemotherapy and immunotherapy, have a range of side effects. Chemotherapy can cause alopecia (hair loss), nausea, fatigue, and increased risk of infections due to lowered white blood cell counts. Immunotherapy, which includes treatments like checkpoint inhibitors, can lead to immune-related side effects such as skin rashes, diarrhea, and fatigue. Specific to scalp cooling used to mitigate chemotherapy-induced alopecia, side effects include headache, scalp pain, and feeling cold. These treatments aim to boost the immune system to target cancer cells, similar to the mechanism of the STEMVAC DNA plasmid-based vaccine.

What prior FDA approvals exist?

FDA approvals for breast cancer treatments have included various approaches such as hormone therapies, chemotherapy, targeted therapies, and immunotherapies. Similar to the STEMVAC trial, which uses a DNA plasmid-based vaccine to enhance the immune system's ability to recognize and destroy breast cancer cells, other immunotherapies like pembrolizumab (Keytruda) have been approved. Pembrolizumab is a monoclonal antibody that targets PD-1, helping the immune system to attack cancer cells. Additionally, trastuzumab (Herceptin) is a targeted therapy that works by binding to the HER2 protein on breast cancer cells, marking them for destruction by the immune system.

What other types of research exist?

Promising novel alternatives to STEMVAC for breast cancer patients include: 1) PD1-Vaxx, a human PD-1 B-cell vaccine that has shown enhanced tumor growth inhibition when combined with HER-2 peptide vaccines (B-Vaxx) in preclinical models. 2) Tislelizumab, an anti-PD-1 inhibitor that has improved progression-free survival (PFS) and overall response rates (ORRs) in combination with chemotherapy in non-small cell lung cancer, suggesting potential applicability in breast cancer. 3) Sintilimab, another anti-PD-1 antibody under FDA review, which has shown improved PFS in combination with chemotherapy in various cancers. These alternatives leverage the immune system to target cancer cells and may offer new avenues for breast cancer treatment.

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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

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

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)

Must not have

Participants with any clinically significant autoimmune disease uncontrolled with treatment

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial studies the effect of a special vaccine called STEMVAC, given with sargramostim, in patients with a hard-to-treat type of breast cancer. The vaccine helps the immune system recognize and attack cancer cells. The goal is to see how well the immune system responds to this treatment. STEMVAC is a type of cancer vaccine designed to stimulate the immune system to recognize and attack 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.

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.

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 breast cancer is triple negative and in stage IB, II, or III.

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I agree not to take systemic steroids until 1 month after my 2nd booster vaccine.

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I am fully active or can carry out light work.

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I am a man willing to use contraception during the study.

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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.

Exclusion Criteria

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

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I have an autoimmune disease that isn't managed well with treatment.

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I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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

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

Primary study objectives

Cellular immune response: incidence

Cellular immune response: magnitude

Secondary study objectives

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

Cardiac disorder

Epistaxis

Multi-bacterial bacteremia causing hemorrhagic shock

Pneumonia

Respiratory failure

Hypoxia

Thormboembolic event

Aspergillus infection

100%

80%

60%

40%

20%

Study treatment Arm

Control Group

Active Sargramostim Treatment Group

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

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: 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

0 / 9Eligibility 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 include surgery, chemotherapy, radiation therapy, hormone therapy, targeted therapy, and immunotherapy. Immunotherapy, such as the DNA plasmid-based vaccine STEMVAC, works by stimulating the patient's immune system to recognize and attack cancer cells. STEMVAC targets specific proteins expressed on breast cancer cells, enhancing the immune system's ability to identify and destroy these cells. This approach is significant for breast cancer patients as it offers a targeted treatment option that can potentially reduce the risk of recurrence and improve overall survival by leveraging the body's natural defense mechanisms.