Vaccine boosts breast cancer fight before surgery
NCT ID NCT04329065
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether adding a vaccine called WOKVAC to standard chemotherapy and targeted therapy before surgery can help the immune system better attack HER2+ breast cancer. About 25 adults with early-stage breast cancer will receive the vaccine alongside their regular treatment. The goal is to see if this combination increases cancer-killing immune cells in the tumor and is safe.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 25 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2022
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients must be at least \>= 18 years of age * Clinical stage I-III breast cancer, HER2+ (per American Society of Clinical Oncology \[ASCO\]/College of American Pathologists \[CAP\] guideline update, 2018), regardless of estrogen receptor (ER)/ progesterone receptor (PR) status and planning to undergo neoadjuvant therapy with either paclitaxel, trastuzumab, and pertuzumab (THP) or docetaxel, carboplatin, trastuzumab, and pertuzumab (TCHP) * Patients who have received prior neoadjuvant chemotherapy are allowed but may only receive paclitaxel, trastuzumab, and pertuzumab for the duration the study * Subjects with Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 * White blood cell (WBC) \>= 3000/mm\^3 (within 4 weeks of initiating study treatment) * Lymphocyte count \>= 500/mm\^3 (within 4 weeks of initiating study treatment) * Absolute neutrophil count (ANC) \>= 1,500/ uL (within 4 weeks of initiating study treatment) * Platelets \>= 75,000/ uL (within 4 weeks of initiating study treatment) * Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN), except patients with Gilbert's syndrome in whom total bilirubin must be \< 3.0 mg/dL (within 4 weeks of initiating study treatment) * Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 3 x institutional upper limit of normal (ULN) (within 4 weeks of initiating study treatment) * Creatinine =\< 2.0 mg/dL or creatinine clearance \> 30 ml/min (within 4 weeks of initiating study treatment) * Left ventricular ejection fraction (LVEF) \>= lower limit of normal for institution performing the multi-gated acquisition (MUGA) or echocardiogram (ECHO) done within 3 months of initiating study treatment * Female patients of child-bearing potential must agree to use dual methods of contraception and have a negative urine pregnancy test at screening, and male patients must use an effective barrier method of contraception if sexually active with a female of child-bearing potential. Acceptable methods of contraception are condoms with contraceptive foam, oral, implantable or injectable contraceptives, contraceptive patch, intrauterine device, diaphragm with spermicidal gel, or a sexual partner who is surgically sterilized or post-menopausal. For both male and female patients, effective methods of contraception must be used throughout the study and for three months following the last vaccine * Ability to understand and willingness to sign a written informed consent document Exclusion Criteria: * 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 * Uncontrolled autoimmune disease requiring active systemic treatment * Known hypersensitivity reaction to the granulocyte-macrophage colony stimulating factor (GM-CSF) adjuvant; any known contra-indication to GM-CSF * Pregnant or breast feeding * Known human immunodeficiency virus (HIV)-positive * History of uncontrolled diabetes * Known current or a history of hepatitis B or C virus, including chronic and dormant states, unless disease has been treated and confirmed cleared * Major surgery within the 4 weeks prior to initiation of study vaccine * Current use of immunosuppressive agents or systemic corticosteroids. Topical, ocular, intra-articular, intranasal, inhalational corticosteroids (with minimal systemic absorption) are allowed. Patients who have received systemic corticosteroids =\< 30 days prior to starting study drug will be excluded \* NOTE: Steroids given as supportive care for the neoadjuvant chemotherapy regimens is allowable per standard of care * Patient is currently enrolled in any other clinical protocol or investigational trial that involves administration of experimental therapy and/or therapeutic devices, or investigational drug * Patients may not be receiving any other investigational agents
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Fred Hutch/University of Washington Cancer Consortium
RECRUITINGSeattle, Washington, 98109, United States
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Other studies related to the condition(s) this trial covers.
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- Can a vaccine train the immune system to hunt down hidden breast cancer cells?