Vaccine Therapy in Treating Patients With HER2-Negative Stage III-IV Breast Cancer

Study Results

Results pending

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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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2027-02-10

Brief Summary

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This phase I trial studies the side effects and best dose of multiantigen deoxyribonucleic acid (DNA) plasmid-based vaccine in treating patients with human epidermal growth factor receptor 2 (HER2)-negative stage III-IV breast cancer. Multiantigen DNA plasmid-based vaccine may target immunogenic proteins expressed in breast cancer stem cells which are the component of breast cancer that is resistant to chemotherapy and has the ability to spread. Vaccines made from DNA may help the body build an effective immune response to kill tumor cells.

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Detailed Description

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OUTLINE: This is a dose-escalation study. Patients are assigned to 1 of 4 arms.

Arm 1: Patients receive CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope plasmid DNA vaccine with recombinant human granulocyte-macrophage colony-stimulating factor (rhuGM-CSF) as 1 injection intradermally (ID) every 28 days for 3 months. Patients may also receive 2 additional booster STEMVAC vaccines at 3 and 9 months after the third vaccine in the absence of unacceptable toxicity or disease progression.

ARM 2: Patients receive CD105/Yb-1/SOX2/CDH3/M2-polyepitope plasmid DNA vaccine with rhuGM-CSF as 2 injections ID every 28 days for 3 months. Patients may also receive 2 additional booster STEMVAC vaccines at 3 and 9 months after the third vaccine in the absence of unacceptable toxicity or disease progression.

ARM 3: Patients receive CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope plasmid DNA vaccine with rhuGM-CSF as 3 injections ID every 28 days for 3 months. Patients may also receive 2 additional booster STEMVAC vaccines at 3 and 9 months after the third vaccine in the absence of unacceptable toxicity or disease progression.

ARM 4: Patients receive CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope plasmid DNA vaccine with rhuGM-CSF as 2 injections ID every 28 days for 3 months. Patients may also receive 1 additional STEMVAC vaccine at 3 months after the third vaccine in the absence of unacceptable toxicity or disease progression.

After completion of study treatment, patients are followed up twice yearly for up to 5 years.

Conditions

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HER2 Negative Breast Carcinoma Recurrent Breast Carcinoma Stage IIIA Breast Cancer Stage IIIB Breast Cancer Stage IIIC Breast Cancer Stage IV Breast Cancer Stage III Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1 (STEMVAC)

Patients receive CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope plasmid DNA vaccine with rhuGM-CSF as 1 injection ID every 28 days for 3 months. Patients may also receive 2 additional booster STEMVAC vaccines at 3 and 9 months after the third vaccine in the absence of unacceptable toxicity or disease progression.

Group Type EXPERIMENTAL

CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine

Intervention Type BIOLOGICAL

Given ID

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Arm 2 (STEMVAC)

Patients receive CD105/Yb-1/SOX2/CDH3/M2-polyepitope plasmid DNA vaccine with rhuGM-CSF as 2 injections ID every 28 days for 3 months. Patients may also receive 2 additional booster STEMVAC vaccines at 3 and 9 months after the third vaccine in the absence of unacceptable toxicity or disease progression.

Group Type EXPERIMENTAL

CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine

Intervention Type BIOLOGICAL

Given ID

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Arm 3 (STEMVAC)

Patients receive CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope plasmid DNA vaccine with rhuGM-CSF as 3 injections ID every 28 days for 3 months. Patients may also receive 2 additional booster STEMVAC vaccines at 3 and 9 months after the third vaccine in the absence of unacceptable toxicity or disease progression.

Group Type EXPERIMENTAL

CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine

Intervention Type BIOLOGICAL

Given ID

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Arm 4 (STEMVAC)

Patients receive CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope plasmid DNA vaccine with rhuGM-CSF as 2 injections ID every 28 days for 3 months. Patients may also receive 1 additional STEMVAC vaccine at 3 months after the third vaccine in the absence of unacceptable toxicity or disease progression.

Group Type EXPERIMENTAL

CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine

Intervention Type BIOLOGICAL

Given ID

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Interventions

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CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine

Given ID

Intervention Type BIOLOGICAL

Laboratory Biomarker Analysis

Correlative studies

Intervention Type OTHER

Other Intervention Names

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CD105/Yb-1/SOX2/CDH3/MDM2 Plasmid Vaccine STEMVAC STEMVAC Th1 Polyepitope Plasmid-based Vaccine

Eligibility Criteria

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Inclusion Criteria

* Patients with stage III-IV HER2 negative breast cancer treated with primary or salvage therapy and now have:

* No evidence of disease (NED), or
* Stable bone only disease
* Patients who have completed standard of care and recovered with mild to no residual toxicity from recent therapy
* Patients must be at least 28 days post cytotoxic chemotherapy, and/or monoclonal antibody therapy (excluding bone-directed therapy), prior to enrollment
* Patients must be at least 28 days post systemic steroids prior to enrollment
* Patients on bisphosphonates, denosumab, and/or endocrine therapy are eligible
* Patients must have Eastern Cooperative Oncology Group (ECOG) performance status score of =\< 1
* Patients must have recovered from major infections and/or surgical procedures, and in the opinion of the investigator, not have any significant active concurrent medical illnesses precluding protocol treatment
* Estimated life expectancy of more than 6 months
* White blood cells (WBC) \>= 3000/mm\^3 (within 30 days of first vaccination)
* Lymphocyte count \>= 800/mm\^3 (within 30 days of first vaccination)
* Platelet count \>= 75,000/mm\^3 (within 30 days of first vaccination)
* Hemoglobin (Hgb) \>= 10 g/dl (within 30 days of first vaccination)
* Serum creatinine \<= 1.2 mg/dl or creatinine clearance \> 60 ml/min (within 30 days of first vaccination)
* Total bilirubin \<= 1.5 mg/dl (within 30 days of first vaccination)
* Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) \<= 2 times upper limit of normal (ULN) (within 30 days of first vaccination)
* Blood glucose \< 1.5 ULN (within 30 days of first vaccination)
* All patients who are having sex that can lead to pregnancy must agree to contraception for the duration of study

Exclusion Criteria

* Patients with any of the following cardiac conditions:

* Symptomatic restrictive 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
* Patients at risk for gastrointestinal bleeding (example: peptic ulcer disease, prolonged daily non-steroidal anti-inflammatory use)
* Patients with any seizure disorder
* Patients with any contraindication to receiving rhuGM-CSF based products
* Patients with any clinically significant autoimmune disease uncontrolled with treatment
* Patients who are simultaneously enrolled in any other treatment study
* Patients who are pregnant or breastfeeding

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No