Combining WOKVAC vaccine with chemotherapy and targeted therapy for breast cancer treatment
A Phase II Study of Concurrent WOKVAC Vaccination With Neoadjuvant Chemotherapy and HER2-Targeted Monoclonal Antibody Therapy
This study is testing if a new vaccine combined with chemotherapy and targeted therapy can help boost the immune response in breast cancer patients before surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Washington Academic / other |
| Drugs / interventions | trastuzumab, pertuzumab, chemotherapy |
| Locations | 1 site (Seattle, Washington) |
| Trial ID | NCT04329065 on ClinicalTrials.gov |
What this trial studies
This phase II trial investigates the use of the WOKVAC vaccine alongside chemotherapy and HER2-targeted monoclonal antibody therapy in patients with breast cancer prior to surgery. The study aims to evaluate the immunologic response and side effects of this combination treatment. Patients will receive the WOKVAC vaccine intradermally, along with paclitaxel and targeted therapies trastuzumab and pertuzumab, over multiple cycles. The goal is to enhance the immune response against tumor cells while managing the disease effectively.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with clinical stage I-III HER2-positive breast cancer planning to undergo neoadjuvant therapy.
Not a fit: Patients with non-HER2-positive breast cancer or those with advanced disease not eligible for neoadjuvant therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes for patients with HER2-positive breast cancer.
How similar studies have performed: Other studies have shown promise in combining immunotherapy with targeted therapies, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Seattle, Washington
- Fred Hutch/University of Washington Cancer Consortium — Seattle, Washington, United States (Recruiting)
Study contacts
- Principal investigator: William Gwin — Fred Hutch/University of Washington Cancer Consortium
- Study coordinator: Jennifer Childs
- Email: childj@uw.edu
- Phone: 206-616-2305
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.