Clinical trial NCT00049062 (phase 2, status: completed)
Conditions: breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: anastrozole, gefitinib
SMILES: CC(C)(C#N)C1=CC(=CC(CN2C=NC=N2)=C1)C(C)(C)C#N, COC1=C(OCCCN2CCOCC2)C=C2C(NC3=CC(Cl)=C(F)C=C3)=NC=NC2=C1
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed breast cancer

               -  Metastatic or locally advanced unresectable disease

          -  At least 1 measurable target lesion that has not been irradiated

               -  New lesions in a previously irradiated field allowed as sites of measurable
                  disease

          -  Progressive disease after more than 2 months of aromatase inhibitor therapy

          -  No known CNS disease or unevaluated CNS symptoms suggestive of brain metastases

          -  Hormone receptor status:

               -  Estrogen receptor or progesterone receptor positive

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Sex

          -  Female

        Menopausal status

          -  Post-menopausal by 1 of the following criteria:

               -  Age 50 and over and has not menstruated during the past year or has castrate
                  follicle-stimulating hormone (FSH) levels (greater than 40 IU/L)

               -  Under age 50 and has castrate FSH levels

               -  Received prior bilateral oophorectomy and has castrate FSH levels

        Performance status

          -  ECOG 0-2

        Life expectancy

          -  At least 12 weeks

        Hematopoietic

          -  Absolute neutrophil count at least 1,500/mm^3

          -  Platelet count at least 100,000/mm^3

        Hepatic

          -  Bilirubin no greater than 1.5 times upper limit of normal (ULN)

          -  ALT or AST no greater than 2.5 times ULN (5 times ULN if liver metastases present)

        Renal

          -  Creatinine no greater than 1.5 times ULN

        Cardiovascular

          -  No history of congestive heart failure requiring therapy

          -  No ventricular arrhythmia requiring therapy

          -  No unstable angina pectoris

          -  No myocardial infarction within the past 6 months

        Other

          -  Able to swallow oral medication

          -  No other malignancy within the past 5 years except nonmelanoma skin cancer or
             carcinoma in situ of the cervix

          -  No known malabsorption condition or other condition that would impair absorption of
             study drug

          -  No active infection

          -  No other concurrent medical condition that would preclude study

          -  No known severe hypersensitivity to ZD 1839 or any excipients

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  Not specified

        Chemotherapy

          -  No prior chemotherapy except in adjuvant setting

          -  No concurrent chemotherapy for breast cancer

        Endocrine therapy

          -  See Disease Characteristics

          -  More than 30 days since other prior hormonal therapy (including hormone replacement
             therapy and megestrol)

          -  Concurrent steroids for other reasons besides skin toxicity allowed

          -  No other concurrent hormonal therapy (including megestrol) for breast cancer

        Radiotherapy

          -  See Disease Characteristics

        Surgery

          -  Recovered from prior oncologic or other major surgery

          -  No concurrent ophthalmic surgery

        Other

          -  More than 30 days since prior anticancer therapy

          -  More than 30 days since prior non-approved or investigational drugs

          -  No prior epidermal growth factor receptor or HER2 blockers

          -  No concurrent phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital,
             Hypericum perforatum, or systemic retinoids

          -  No other concurrent investigational therapy for breast cancer

          -  Concurrent bisphosphonates for metastatic bone disease allowed