Concurrent WOKVAC Vaccination, Chemotherapy, and HER2-Targeted Monoclonal Antibody Therapy Before Surgery for the Treatment of Patients With Breast Cancer
NCT ID: NCT04329065
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
25 participants
INTERVENTIONAL
2022-04-20
2027-08-15
Brief Summary
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Detailed Description
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Patients receive WOKVAC intradermally (ID) on day 13. Treatment repeats for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive paclitaxel via infusion on days 1, 8, and 15 or docetaxel intravenously (IV) and carboplatin IV on day 1, and trastuzumab IV and pertuzumab IV on day 1. The chemo and trastuzumab and pertuzumab will most likely be given by the patient's own oncologist per standard of care. Treatment repeats for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo ultrasound imaging or magnetic resonance imaging and biopsy on study and blood sample collection throughout the study.
After completion of study treatment, patients are followed up annually for up to 5 years from enrollment.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (WOKVAC, paclitaxel, trastuzumab, pertuzumab)
Patients receive WOKVAC ID on day 13. Treatment repeats for up to 3 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive paclitaxel via infusion on days 1, 8, and 15 or docetaxel IV and carboplatin IV on day 1, and trastuzumab IV and pertuzumab IV on day 1. The chemo and trastuzumab and pertuzumab will most likely be given by the patient's own oncologist per standard of care. Treatment repeats for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo ultrasound imaging or magnetic resonance imaging and biopsy on study and blood sample collection throughout the study.
pUMVC3-IGFBP2-HER2-IGF1R Plasmid DNA Vaccine
Given ID
Paclitaxel
Given via infusion
Trastuzumab
Given IV
Pertuzumab
Given IV
Docetaxel
Given IV
Carboplatin
Given IV
Ultrasound Imaging
Undergo ultrasound imaging
Biopsy Procedure
Undergo biopsy
Biospecimen Collection
Undergo blood sample collection
Interventions
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pUMVC3-IGFBP2-HER2-IGF1R Plasmid DNA Vaccine
Given ID
Paclitaxel
Given via infusion
Trastuzumab
Given IV
Pertuzumab
Given IV
Docetaxel
Given IV
Carboplatin
Given IV
Ultrasound Imaging
Undergo ultrasound imaging
Biopsy Procedure
Undergo biopsy
Biospecimen Collection
Undergo blood sample collection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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United States Department of Defense
FED
University of Washington
OTHER
Responsible Party
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Principal Investigators
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William Gwin
Role: PRINCIPAL_INVESTIGATOR
Fred Hutch/University of Washington Cancer Consortium
Locations
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Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
Countries
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Central Contacts
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Facility Contacts
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Jennifer Childs
Role: primary
Other Identifiers
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NCI-2020-01662
Identifier Type: REGISTRY
Identifier Source: secondary_id
W81XWH-16-1-0385
Identifier Type: OTHER
Identifier Source: secondary_id
10159
Identifier Type: OTHER
Identifier Source: secondary_id
RG1005296
Identifier Type: -
Identifier Source: org_study_id