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Vaccine Therapy in Treating Patients With Stage IV Hormone Receptor Positive Breast Cancer

Complete title: Phase II Study to Evaluate the Development of HER2/neu (HER2)-Specific Memory T Cells after HER2 Peptide-Based Vaccination in Patients with Advanced Stage HER2+ Breast Cancer

Research Study Number       7905
Principal Investigator       Lupe Salazar, MD
Phase       II

Look up trial at NIH

Research Study Description

This phase II trial studies how well vaccine therapy works in treating patients with stage IV hormone receptor positive breast cancer. Vaccines made from peptides may help the body build an effective immune response to kill tumor cells

Eligibility Criteria (must meet the following to participate in this study)

Ages Eligible for Study: 19 Years and older

Genders Eligible for Study: Both

- Patients with HER2+ stage IV breast cancer that have been maximally treated and not in a complete remission

- Patients must have measurable disease per imaging studies performed within 60 days of enrollment as described below:

--- Extra skeletal disease that can be measured with conventional or spiral computed tomography (CT) techniques

-- Skeletal or bone-only disease that is measurable by fludeoxyglucose F 18 (FDG) positron emission tomography (PET) or magnetic resonance imaging (MRI)

- Patients can be receiving trastuzumab and/or lapatinib and/or hormonal therapy and/or bisphosphonate therapy

- HER2 overexpression in the primary tumor or metastasis by immunohistochemistry (IHC) of 3+, or documented gene amplification by fluorescent in situ hybridization (FISH) analysis

- Patients must be human leukocyte antigen (HLA)-A2 positive

- Eastern Cooperative Oncology Group (ECOG)/Zubrod scale of =< 1

- Patients must be off immunosuppressive treatments (i.e., chemotherapy or systemic steroids) 3 weeks prior to first vaccine

- Patients on trastuzumab must have a baseline left ventricular ejection fraction (LVEF) measured by multi gated acquisition scan (MUGA) or echocardiogram (ECHO) >= the lower limit of normal for the facility within 3 months of enrollment to study

- Subjects of reproductive ability must agree to use contraceptives during the entire study period

Other eligibility criteria may apply.

Exclusions (conditions that would prevent participation in this study)

- White blood cell (WBC) < 3000/mm^3

- Hemoglobin (Hgb) < 10 mg/dl

- Platelets < 100,000/mm^3

- Serum creatinine > 2.0 mg/dl

- Serum bilirubin > 1.5 x upper limit of normal

- Any contraindication to receiving sargramostim (GM-CSF) based vaccine products

- Concurrent enrollment in other treatment studies

- New York Heart Association functional class III-IV heart failure, symptomatic pericardial effusion, or unstable angina

- Pregnant or breast-feeding women

- History of disorders associated with immunosuppression such as human immunodeficiency virus (HIV)

- Active brain metastasis

Other exclusion criteria may apply.

Research Study Number       7905
Contact       Seattle Cancer Care Alliance Intake Office
Telephone       800-804-8824 / 206-288-1024

Breast Cancer; Solid Tumors

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Please remember:

  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.

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