Disseminated Tumor Cells in Blood and Bone Marrow Samples from Patients Previously Treated for Breast Cancer

Inclusion Criteria

• Histologically-confirmed primary invasive breast cancer within 5 years of study entry
• Pathologically-confirmed invasive breast cancer in axillary lymph nodes or tumor with triple negative subtype: negative estrogen receptor (ER), progesterone receptor (PR) and Her2-overexpression by American Society of Clinical Oncology-College of American Pathologists (ASCO-CAP) guidelines or tumor with a breast cancer recurrence score of >= 18 per the Genomic Health Oncotype DX breast cancer test, or residual disease after neoadjuvant chemotherapy
• Completed all primary therapy (surgery, [neo]adjuvant chemotherapy and adjuvant radiation) for the index malignancy with
• No evidence of local or distant recurrent disease by physical examination, blood tests (complete blood count [CBC], liver function tests [LFTs], alkaline phosphatase [alk phos]), or symptom-directed imaging, per National Comprehensive Cancer Network (NCCN) guidelines
• Prothrombin time (PT) and partial thromboplastin time (PTT) =< 1.5 x upper limit of normal (ULN) per institutional laboratory range; for patients on therapeutic anti-coagulants, medication must be clinically held peri-procedure per standard clinical management
• Willing to undergo bone marrow aspiration and blood specimen collection per protocol specifications
• Able to give informed consent
• Patient has no evidence of meeting exclusion criteria for companion clinical trials

Exclusion Criteria

• Concurrent enrollment on another investigational therapy
• Patients receiving chronic, high dose systemic treatment with corticosteroids defined as: chronic use of cortisone > 50 mg; hydrocortisone > 40 mg, prednisone > 10 mg, methylprednisone > 8 mg or dexamethasone > 1.5 mg; or another immunosuppressive agent; topical or inhaled corticosteroids are allowed
• Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as: * Symptomatic congestive heart failure of New York heart Association class III or IV * Unstable angina pectoris, myocardial infarction within 6 months of start of study drug, serious uncontrolled cardiac arrhythmia or any other clinically significant cardiac disease * Severely impaired lung function with a previously documented spirometry and diffusing capacity of the lungs for carbon monoxide (DLCO) that is 50% of the normal predicted value and/or O2 saturation that is 88% or less at rest on room air * Uncontrolled diabetes as defined by fasting serum glucose > 1.5 x ULN * Active (acute or chronic) or uncontrolled severe infections * Liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis * A known history of human immunodeficiency virus (HIV) seropositivity as reported by the patient * Impairment of gastrointestinal function or gastrointestinal disease (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome or small bowel resection) * Patients with an active, bleeding diathesis
• Female patients who are pregnant or breast feeding; women of childbearing potential must have a negative urine or serum pregnancy test
• Patients who have received prior treatment with an mechanistic target of rapamycin (mTOR) inhibitor (sirolimus, temsirolimus, everolimus)
• Patients with a known hypersensitivity to everolimus or other rapamycins (sirolimus, temsirolimus) or to its excipients
• A detailed assessment of hepatitis B/C medical history and risk factors must be done at screening for all patients; hepatitis B virus (HBV) deoxyribonucleic acid (DNA) and hepatitis C virus (HCV) RNA polymerase chain reaction (PCR) testing are required at screening for all patients with a positive medical history based on risk factors and/or confirmation of prior HBV/HCV infection