Endocrine Therapy + OSI-906 With or Without Erlotinib for Hormone-Sensitive Metastatic Breast Cancer

Exclusion Criteria

• •Locally recurrent resectable breast cancer.
• •Pregnant or lactating women.
• •Patients must not have had \> than 4 prior chemotherapy treatments in the metastatic setting. This restriction does not include endocrine therapies or single agent biologic therapies.
• •Use of CYP3A4 and CYP1A2 modifiers or drugs that prolong QTcF with high risk for Torsade de Pointes (see Appendix A)
• •Any kind of malabsorption syndrome significantly affecting gastrointestinal function.
• •History of other malignancy within 5 years prior to enrollment. Subjects with a history of completely resected non-melanoma skin cancer or successfully treated in situ carcinomas are eligible.
• •Patients with baseline QTcF\> 450 msec
• •Patients with diabetes, glucose \> 160 mg/dL or receiving ongoing antihyperglycemic therapies
• •Uncontrolled intercurrent illness including, but not limited to:
• •* ongoing or active infection requiring parenteral antibiotics
• •* impairment of lung function (COPD \> grade 2, lung conditions requiring oxygen therapy)
• •* symptomatic congestive heart failure (class III or IV of the New York Heart Association classification for heart disease)
• •* unstable angina pectoris, angioplasty, stenting, or myocardial infarction within 6 months
• •* uncontrolled hypertension (systolic blood pressure \>180 mm Hg or diastolic blood pressure \>100 mm Hg, found on two consecutive measurements separated by a 1-week period despite adequate medical support)
• •* clinically significant cardiac arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia that is symptomatic or requires treatment \[National Cancer Institute -Common Terminology Criteria for Adverse Events, Version 4.0, grade 3\]
• •* psychiatric illness/social situations that would compromise patient safety or limit compliance with study requirements including maintenance of a compliance/pill diary
• •Patients with symptomatic brain metastases (patients with a history of brain metastases must be clinically stable for more than 3 weeks from completion of radiation treatment and not taking steroids or therapeutic anticonvulsants that are CYP3A4 modifiers)
• •Patients with asymptomatic brain metastasis on prophylactic anticonvulsants that are CYP3A4 modifiers
• •Concurrent anti-cancer therapy (chemotherapy, radiation therapy, surgery, immunotherapy, hormonal therapy, biologic therapy) other than the ones specified in the protocol. Patients must have discontinued the above cancer therapies for 1 week prior to the first dose of study medication, as well as recovered from toxicity (to ≤ than grade 1, except for alopecia, neuropathy, and ANC, which should be ≥ 1250/mm3) induced by previous treatments. Any other investigational drugs should be discontinued 2 weeks prior to the first dose of study medication.
• •Prior therapy with an IGF-1R inhibitor