Biospecimen Testing in Studying the Impact of Endocrine Therapies on the Number and Function of Immune Cells in Pre- and Post-menopausal Patients with Early Stage Estrogen Receptor Positive Breast Cancer

Inclusion Criteria

• ALL ENDOCRINE THERAPY COHORTS: Early stage breast cancer including T1-3, N0-3
• ALL ENDOCRINE THERAPY COHORTS: Histologically documented estrogen receptor positive adenocarcinoma of the breast that is (any progesterone status allowed): * Estrogen receptor (ER) positive defined as >= 10 % tumor cells positive for ER by immunohistochemistry (IHC), irrespective of staining intensity * HER2 negative status is determined by: ** IHC 1+, as defined by incomplete membrane staining that is faint/barely perceptible and within > 10% of invasive tumor cells, or ** IHC 0, as defined by no staining observed or membrane staining that is incomplete and is faint/barely perceptible and within =< 10% of the invasive tumor cells, or ** Fluorescence In Situ Hybridization (FISH) negative based on: *** Single-probe average HER2 copy number < 4.0 signals / cell, or *** Dual-probe HER2/CEP17 ratio < 2.0 with an average HER2 copy number < 4.0 signals /cell
• ALL ENDOCRINE THERAPY COHORTS: Patients should have plans to initiate standard of care endocrine therapy in the adjuvant setting meeting one of specifications per primary provider, not to be dictated by protocol
• ALL ENDOCRINE THERAPY COHORTS: Patients can have had neoadjuvant or adjuvant chemotherapy with resolution of all hematologic toxicity to less than grade 1 by Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.0 (e.g. hemoglobin [Hg] >= 10 d/dL, platelets 75,000 mm^3, neutrophil > 1500 mm^3)
• ALL ENDOCRINE THERAPY COHORTS: Patients should be willing to provide an archival tumor specimen from their definitive surgery
• ALL ENDOCRINE THERAPY COHORTS: Able and willing to complete the informed consent process
• ALL ENDOCRINE THERAPY COHORTS: Available to participate for the planned duration of the study (6 months)
• ALL ENDOCRINE THERAPY COHORTS: Agree to have bio-specimens stored for future research
• HEALTHY CONTROLS: No known significant health problems
• HEALTHY CONTROLS: Available to participate for the planned duration of the investigational study (6 months)
• HEALTHY CONTROLS: Able and willing to complete the informed consent process
• HEALTHY CONTROLS: Agree to have blood stored for future studies
• HEALTHY CONTROLS: Premenopausal women must have a history of regular menses defined as occurring monthly at regular intervals
• HEALTHY CONTROLS: Postmenopausal women are defined as prior bilateral oophorectomy, 60 or older, age less than 60 years; amenorrheic for 12 or more months in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression; and follicle-stimulating hormone (FSH) and plasma estradiol in the postmenopausal range

Exclusion Criteria

• ALL COHORTS: Relapsed or metastatic breast cancer
• ALL COHORTS: History of cancer or concurrent active malignancy (excluding basal cell skin cancer, resected squamous cell carcinoma of the skin)
• ALL COHORTS: Receipt of neoadjuvant or previous endocrine therapy including ovarian function suppression in the neoadjuvant setting
• ALL COHORTS: Current use of hormonal birth control (copper intrauterine device [IUD] allowed) or estrogen replacement therapy
• ALL COHORTS: Known to have a condition in which repeated blood draws pose more than minimal risk for the subject such as hemophilia, other severe coagulation disorders or significantly impaired venous access
• ALL COHORTS: Concurrent enrollment in a therapeutic clinical trial involving novel drug therapies
• ALL COHORTS: Active autoimmune disease that has required systemic treatment in past year (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, or similar treatment) is not considered a form of systemic treatment
• ALL COHORTS: Immunodeficient subjects, e.g., receiving systemic steroid therapy or any other form of immunosuppressive therapy within 30 days prior to the first dose of endocrine therapy treatment
• ALL COHORTS: Concurrent use of other oncologic therapies in the adjuvant setting other than bisphosphonates
• ALL COHORTS: Active or ongoing infection
• ALL COHORTS: Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease, active bleeding diatheses including any subjects known to have evidence of acute or chronic hepatitis B, hepatitis C or human immunodeficiency virus (HIV), or psychiatric illness / social situations that would limit compliance with study requirements or compromise the ability of the subject to give written informed consent
• ALL COHORTS: Pregnant or breastfeeding