Clinical trial for Anatomic Stage I Breast Cancer AJCC v8
Official title Concurrent WOKVAC Vaccination, Chemotherapy, and HER2-Targeted Monoclonal Antibody Therapy Before Surgery for the Treatment of Patients With Breast Cancer
ClinicalTrials.gov ID: NCT04329065
What this study is testing
What is pUMVC3-IGFBP2-HER2-IGF1R Vaccine (WOKVAC)?
An investigational plasmid DNA vaccine being studied for early-stage breast cancer. is designed to stimulate the immune system to recognize and attack tumor cells expressing HER2 and IGF1R antigens.
Also referred to as WOKVAC.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study looks at how the WOKVAC vaccine works with chemotherapy and HER2‑targeted antibodies, and checks for side effects.
- Who it's for
- Women with stage I, II, or III breast cancer who are scheduled for surgery
- What's involved
- Participants receive the WOKVAC vaccine together with paclitaxel, trastuzumab, and pertuzumab before their operation, and will have regular medical visits and tests.
- Time commitment
- The trial lasts about 6–8 weeks before surgery, with several clinic visits for treatment and monitoring.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 5 years
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Patients who have received prior neoadjuvant chemotherapy are allowed but may only receive paclitaxel, trastuzumab, and pertuzumab for the duration...
- people 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)
You likely can't join if
- 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
See the full eligibility 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...
- Patients who have received prior neoadjuvant chemotherapy are allowed but may only receive paclitaxel, trastuzumab, and pertuzumab for the duration the study
- people 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 =\ 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...
- Ability to understand and willingness to sign a written informed consent document
- 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.
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Seattle, Washington, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.