This study gathers information from the blood cells and tumor tissue during treatment with anti-HER2 therapies, such as trastuzumab, pertuzumab, lapatinib, or neratinib, in patients with HER2 positive stage I-IV breast cancer who are scheduled to start anti-HER2 therapy. The information gained from this study may help researchers better understand the relation between cell response and anti-HER2 therapies.
Age >= 18 years
Histological confirmed adenocarcinoma of the breast stage I-IV from the American Joint Committee on Cancer staging 8th edition
Any estrogen receptor (ER) or progesterone receptor (PR) but HER2 positive defined as per the most current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guideline
Provide written informed consent
Immunocompromised patients including patients known to be human immunodeficiency virus (HIV) positive
Receiving systemic steroid therapy or any other immunosuppressive therapy =< 30 days prior to registration. NOTE: Inhaled steroids, low-dose corticosteroids (e.g. equivalent to or less than oral prednisone 10 mg daily), and steroid use for primary prevention of nausea per institutional guidelines are allowed.
Stage I-IV HER2 positive breast cancer patients
Case-only
Prospective
Biospecimen Collection
Procedure/SurgeryUndergo collection of blood and tumor tissue samples
HER2 specific T-cell response and clinical response
Defined as (1) a 2-fold or greater increase in HER2-specific T cells or HER2-specific antibodies at any point during treatment if pre-treatment levels of HER2-specific T cells or antibodies are detectable, or (2) HER2-specific T cells or HER2-specific antibodies at any point during treatment if pretreatment levels of HER-2 binding activity are non-detectable.
Antibody response and clinical response
Defined as (1) a 2-fold or greater increase in HER2-specific T cells or HER2-specific antibodies at any point during treatment if pre-treatment levels of HER2-specific T cells or antibodies are detectable, or (2) HER2-specific T cells or HER2-specific antibodies at any point during treatment if pretreatment levels of HER-2 binding activity are non-detectable.
Proportion of patients who develop HER2-specific T cell and endogenous antibody responses
A two sided alpha=0.10 test of proportions will be used to assess whether the proportion of women who develop a HER2-specific immune response differs between the women who develop a tumor response and those who do not.
Levels of HER2 CD4 T-cells, HER2 CD8 T-cells, and HER2-specific antibodies
Descriptive statistics will be used to quantify T cell or antibody response within each cohort of patients, namely (neo)adjuvant vs. metastatic setting and within each anti-HER2 treatments (i.e. trastuzumab, pertuzumab, lapatinib, or neratinib).
Association between combination therapy and immunity to common breast cancer associated antigens
Descriptive statistics will be used.
Association between HER2-specific T cell or antibody immunity and improved progression-free survival
Descriptive statistics will be used.
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