Clinical trial NCT01013506 (phase 2, status: withdrawn)
Conditions: breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: igf-1r inhibitor osi-906, erlotinib hydrochloride, goserelin, letrozole
SMILES: C[C@@]1(O)C[C@@H](C1)C1=NC(=C2N1C=CN=C2N)C1=CC=C2C=CC(=NC2=C1)C1=CC=CC=C1, COCCOC1=CC2=C(C=C1OCCOC)C(NC1=CC(=CC=C1)C#C)=NC=N2, CC(C)C[C@H](NC(=O)[C@@H](CC1=CNC2=CC=CC=C12)NC(=O)[C@H](CC1=CC=C(O)C=C1)NC(=O)[C@H](CO)NC(=O)[C@H](CC1=CNC2=C1C=CC=C2)NC(=O)[C@H](CC1=CNC=N1)NC(=O)[C@@H]1CCC(=O)N1)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N1CCC[C@H]1C(=O)NCC(N)=O, N#CC1=CC=C(C=C1)C(N1C=NC=N1)C1=CC=C(C=C1)C#N
Reason stopped: 
    study was abandoned before opening to accrual. replaced by another study.
  
Eligibility 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