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

You may not qualify if:

• 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 \[National Cancer Institute -Common Terminology Criteria for Adverse Events, Version 4.0, grade 3\]
• +5 more criteria