Phase 2, Endocrine Therapy + OSI-906 With or Without Erlotinib for Hormone-sensitive Metastatic Breast Cancer

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically confirmed invasive breast carcinoma
• •* Stage IV disease
• •No locally recurrent resectable disease
• •No symptomatic brain metastases
• •* History of brain metastases allowed provided the patient is clinically stable for \> 3 weeks after completion of radiotherapy AND is not taking steroids or therapeutic anticonvulsants that are CYP3A4 modifiers
• •Hormone receptor status:
• •* Estrogen receptor and/or progesterone receptor positive tumor by immunohistochemistry (IHC)
• •PATIENT CHARACTERISTICS:
• •Pre- or post-menopausal
• •ECOG performance status 0-1
• •Life expectancy ≥ 6 months
• •ANC ≥ 1,250/mm\^3
• •Platelet count ≥ 100,000/mm\^3
• •Creatinine ≤ 1.5 times upper limit of normal (ULN)
• •Bilirubin ≤ 1.5 times ULN (≤ 3 times ULN if liver metastasis is present)
• •* For patients with Gilbert syndrome, direct bilirubin will be measured instead of total bilirubin
• •SGOT and SGPT ≤ 1.5 times ULN (≤ 3 times ULN if liver metastasis is present)
• •Alkaline phosphatase ≤ 1.5 times ULN (≤ 3 times ULN if liver metastasis is present)
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective barrier contraception during and for 3 months after completion of study therapy
• •Able to swallow and retain oral medication
• •Baseline QTc ≤ 450 msec
• •No other invasive cancer within the past 5 years except for completely resected basal cell or squamous cell skin cancer or successfully treated cervical carcinoma in situ
• •No malabsorption syndrome significantly affecting gastrointestinal function
• •No diabetes, fasting glucose \> 150mg/dL, or receiving ongoing anti-hyperglycemic therapies
• •No concurrent uncontrolled illness including, but not limited to, any of the following:
• •* Ongoing or active infection requiring parenteral antibiotics
• •* Impaired lung function (i.e., COPD or lung conditions requiring oxygen therapy)
• •* Symptomatic congestive heart failure (NYHA class III or IV heart disease)
• •* Unstable angina pectoris, angioplasty, stenting, or myocardial infarction within the past 6 months
• •* Uncontrolled hypertension, defined as systolic BP \> 180 mm Hg or diastolic BP \> 100 mm Hg on two consecutive measurements taken ≥ 1 week apart, despite adequate medical support
• •* Clinically significant cardiac arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, or ventricular tachycardia that is symptomatic or requires treatment)
• •* Psychiatric illness and/or social situation that would compromise patient safety or limit compliance with study requirements, including maintenance of a compliance/pill diary
• •PRIOR CONCURRENT THERAPY:
• •See Disease Characteristics
• •Recovered from prior therapy
• •At least 2 weeks since prior investigational drugs
• •No more than 4 prior chemotherapy treatments in the metastatic setting
• •* Does not include endocrine therapy or single-agent biologic therapy
• •No concurrent CYP3A4 or CYP1A2 modifiers
• •No other concurrent anticancer therapy, including chemotherapy, radiotherapy, surgery, immunotherapy, hormonal therapy, or biologic therapy
• •* Concurrent radiotherapy to painful bone metastases or areas of impeding bone fracture allowed provided radiotherapy is initiated before study therapy