Alisertib With or Without Fulvestrant in Treating Patients With Locally Advanced or Metastatic, Endocrine-Resistant Breast Cancer

Inclusion Criteria

• PRE-REGISTRATION ELIGIBILITY
• Post-menopausal defined as
• Age >= 60 and amenorrhea > 12 consecutive months, OR
• Age 12 consecutive months without another cause and documented follicle stimulating hormone (FSH) level of > 35 mIU/mL, OR
• Previous bilateral oophorectomy
• Histologic proof of metastatic or locally advanced, unresectable breast cancer
• History of ER positive (+) (>= 10% of cells positive on hematoxylin and eosin stain [H&E]), HER2 negative (-) breast cancer disease, either as a
• History of primary, operable ER+/HER2- invasive breast cancer OR
• History of de novo metastatic breast cancer that is ER+/HER2-
• Note: HER2- (negative) disease defined as one of the following:
• HER2 immunohistochemistry (IHC) expression of 0, 1+ and in-situ hybridization (ISH) non-amplified
• HER2 IHC expression of 0, 1+ and ISH not done
• HER2 IHC expression of 2+ and ISH non-amplified
• IHC not done and ISH non-amplified
• Prior treatment
• No more than two prior chemotherapy regimens in the metastatic setting
• Prior treatment with fulvestrant in the metastatic setting is required, except for patients with a history of ER-negative metastatic breast cancer
• Unlimited prior endocrine therapy regimens in the metastatic setting are allowed
• No prior treatment with an aurora Kinase inhibitor (either an aurora A or pan-aurora kinase inhibitor)
• Disease that is measurable where:
• A non-nodal lesion is considered measurable if its longest diameter can be accurately measured as >= 2.0 cm with chest x-ray, or as >= 1.0 cm with computed tomography (CT) scan, CT component of a positron emission tomography (PET)/CT, or magnetic resonance imaging (MRI)
• A malignant lymph node is considered measurable if its short axis is >= 1.5 cm when assessed by CT scan (CT scan slice thickness recommended to be no greater than 5 mm); Note: tumor lesions in a previously irradiated area are not considered measurable disease; Note: disease that is measurable by physical examination only is not eligible
• No history of tumors involving spinal cord or heart
• History of brain metastases as per the following criteria:
• Patients with a history of resected brain metastases are eligible only if they are asymptomatic and have stable MRI scans for 3 consecutive months, including 160/90)
• No history of uncontrolled sleep apnea syndrome and other conditions that could result in excessive daytime sleepiness, such as severe chronic obstructive pulmonary disease; requirement for supplemental oxygen
• No other active second malignancy other than non-melanoma skin cancers and in situ cervical cancers within 5 years of registration
• NOTE: A second malignancy is not considered active if all treatment for that malignancy is completed and the patient has been disease-free for at least 5 years prior to registration
• Ability to provide written informed consent
• Willing to return to enrolling institution for follow-up during the active treatment; event monitoring following completion of therapy may occur outside the enrolling institution
• No history of myocardial infarction = = 1500/mm^3
• Platelet count >= 100,000/mm^3
• Hemoglobin >= 9.0 g/dL
• Total bilirubin = = 45 ml/min using the Cockcroft-Gault formula
• Willing to provide blood and tissue for correlative research purposes

Exclusion Criteria

• REGISTRATION EXCLUSION CRITERIA
• Any of the following therapies prior to registration:
• Chemotherapy =< 21 days
• Immunotherapy =< 21 days
• Biologic therapy =< 21 days
• Hormonal therapy =< 14 days
• Monoclonal antibodies =< 14 days
• Radiation therapy =< 14 days
• Administration of myeloid growth factors or platelet transfusion =< 14 days prior to registration
• Systemic infection requiring intravenous (IV) antibiotic therapy =< 14 days prior to registration
• Treatment with clinically significant enzyme inducers, such as the enzyme-inducing antiepileptic drugs phenytoin, carbamazepine or phenobarbital, or rifampin, rifabutin, rifapent