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RecruitingPhase 2

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

A Phase II Study of Concurrent WOKVAC Vaccination With Neoadjuvant Chemotherapy and HER2-Targeted Monoclonal Antibody Therapy

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 5 years
  • Procedures mentioned: Infusions, Blood draws, MRI scans, Ultrasound, Biopsies

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the WOKVAC vaccine given with chemotherapy and HER2-targeted drugs before breast cancer surgery. It looks at side effects and how the body's immune system responds. It is for adults with stage I–III HER2-positive breast cancer, which has a protein called HER2 that helps cancer cells grow.

This phase II trial studies the immunologic response and side effects of using the WOKVAC vaccine in combination with chemotherapy and HER2-targeted monoclonal antibody therapy before surgery in treating patients with breast cancer. Vaccines like WOKVAC are made from tumor-associated antigens which may help the body build an effective immune response to kill tumor cells. Chemotherapy drugs, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Trastuzumab and pertuzumab are forms of targeted therapy because they work by attaching themselves to specific molecules (receptors) on the surface of tumor cells, known as HER2 receptors. When trastuzumab and pertuzumab attach to HER2 receptors, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body's immune system. Giving the WOKVAC vaccine at the same time (concurrently) with paclitaxel, trastuzumab, and pertuzumab before surgery may kill more tumor cells.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 or older.
  • Have stage I–III HER2-positive breast cancer, with any hormone receptor status.
  • Plan to receive treatment before surgery with paclitaxel, trastuzumab, and pertuzumab, or docetaxel, carboplatin, trastuzumab, and pertuzumab.
  • Prior chemotherapy before surgery is allowed, but during the study you may receive only paclitaxel, trastuzumab, and pertuzumab.
  • Be fully active or able to do light work despite limits on hard physical activity.
  • Meet blood cell, liver, and kidney test limits within 4 weeks before treatment. A heart scan within 3 months must show normal pumping strength.
  • If you can become pregnant, have a negative pregnancy test and use two birth control methods. Men having sex with a woman who can become pregnant must use a barrier method, such as a condom. Use birth control during the study and for 3 months after the last vaccine.
  • Be able to understand the study and willing to sign a consent form.

Who can't join

  • Certain heart problems: a stiff heart muscle with symptoms, an enlarged heart muscle, unstable chest pain in the past 4 months, severe heart failure under treatment, or fluid around the heart causing symptoms.
  • An uncontrolled disease in which the immune system attacks the body that needs whole-body treatment, or a history of uncontrolled diabetes.
  • A known allergy to GM-CSF, a substance used to boost the vaccine's immune effect, or another medical reason you cannot receive it.
  • Pregnancy or breastfeeding.
  • Known HIV infection, or current or past hepatitis B or C, unless treated and confirmed cleared.
  • Major surgery within 4 weeks before starting the vaccine.
  • Current immune-suppressing drugs or whole-body steroids, or whole-body steroids within 30 days before study treatment. Local steroids with little absorption into the body and steroids used to support chemotherapy are allowed.
  • Taking other experimental drugs or joining another study that gives experimental treatment or treatment devices.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 \* 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

Study sites (1)

WA