Concurrent WOKVAC Vaccination, Chemotherapy, and HER2-Targeted Monoclonal Antibody Therapy Before Surgery for the Treatment of Patients With Breast Cancer

Launched by UNIVERSITY OF WASHINGTON · Mar 30, 2020

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment approach for patients with breast cancer by combining a vaccine called WOKVAC with chemotherapy and targeted therapy before surgery. The WOKVAC vaccine aims to help the body recognize and attack cancer cells, while chemotherapy drugs like paclitaxel work to stop the growth of these cells. The targeted therapies, trastuzumab and pertuzumab, specifically attach to certain markers on cancer cells to block their growth signals. By using these treatments together, the researchers hope to improve the effectiveness of the therapy and reduce the amount of cancer present at the time of surgery.

To participate in this trial, individuals must be at least 18 years old and have certain stages of HER2-positive breast cancer. Other requirements include having adequate blood counts and organ function. Participants can expect regular monitoring and assessments throughout the study, and they will receive the vaccine alongside chemotherapy and targeted treatments before their surgery. It's important for potential participants to discuss any existing health conditions or medications with their doctor to ensure their safety and eligibility for the trial.

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Eligibility 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
• • 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