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

Stopped early · Phase 2

Conditions studied: HER2-positive Breast Cancer, Male Breast Cancer, Recurrent Breast Cancer, Stage IV Breast Cancer

In brief

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.

Key facts

Study ID

NCT01729884

Run by

University of Washington

People needed

3

Starts

2012-12-01

Last updated by the study team

2017-04-11

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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