Clinical trial NCT00066378 (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

               -  Radiologically or clinically evident metastatic or locally recurrent disease

               -  Locally advanced disease in elderly patients

               -  Bone metastases only allowed

          -  Failed prior tamoxifen therapy

          -  No rapidly progressive visceral metastases

          -  No uncontrolled CNS metastases

          -  Hormone receptor status:

               -  Estrogen receptor and/or progesterone receptor positive

        PATIENT CHARACTERISTICS:

        Age

          -  Postmenopausal

        Sex

          -  Female

        Menopausal status

          -  Postmenopausal, defined by any of the following:

               -  Natural menopause with last menses more than 1 year ago

               -  Radiotherapy-induced oophorectomy with last menses more than 1 year ago

               -  Chemotherapy-induced menopause with last menses more than 1 year ago AND serum
                  follicle-stimulating hormone and luteinizing hormone and plasma estradiol levels
                  clearly in the postmenopausal range

               -  Surgical castration

        Performance status

          -  ECOG 0-2

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Not specified

        Hepatic

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

          -  Transaminases no greater than 2.5 times ULN

          -  No unstable or uncompensated hepatic disease

        Renal

          -  No unstable or uncompensated renal disease

        Cardiovascular

          -  No unstable or uncompensated cardiac disease

        Pulmonary

          -  No unstable or uncompensated pulmonary disease

          -  No clinically active interstitial lung disease

               -  Asymptomatic chronic stable radiographic changes are allowed

        Other

          -  No severe or uncontrolled systemic disease

          -  No other malignancy within the past 5 years except adequately treated carcinoma in
             situ of the cervix, nonmelanoma skin cancer, or contralateral breast cancer

          -  No psychological, familial, sociological or geographical condition that would preclude
             study compliance and follow-up

          -  No grade 2 or greater unresolved chronic toxicity from prior anticancer therapy

          -  No unresolved ocular inflammation or infection

          -  No known hypersensitivity to anastrozole or gefitinib or any of their excipients

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  No prior trastuzumab (Herceptin)

          -  No concurrent biologic therapy

        Chemotherapy

          -  No more than 1 line of prior chemotherapy in the adjuvant or metastatic setting

          -  No concurrent chemotherapy

        Endocrine therapy

          -  At least 2 years since prior aromatase inhibitors (e.g., anastrozole, letrozole, or
             exemestane) in the adjuvant setting

          -  Prior tamoxifen or fulvestrant in the adjuvant and/or metastatic setting allowed

          -  No prior aromatase inhibitors for metastatic disease

          -  No other concurrent hormonal therapy

        Radiotherapy

          -  No concurrent radiotherapy to any metastatic site

        Surgery

          -  No surgery during and within 4 days after the last dose of gefitinib

        Other

          -  At least 30 days since prior investigational drugs

          -  No prior anti-epidermal growth factor therapy

          -  No prior anti-vascular endothelial growth factor therapy (i.e., tyrosine kinase
             inhibitor receptor)

          -  No concurrent administration of any of the following drugs:

               -  Phenytoin

               -  Carbamazepine

               -  Rifampin

               -  Phenobarbital

               -  Hypericum perforatum (St John's Wort)

          -  No other concurrent investigational drugs or treatment

          -  No other concurrent cancer treatment

          -  No concurrent systemic retinoids

          -  Concurrent bisphosphonate therapy for the treatment and prevention of bony metastases
             is allowed provided therapy was initiated prior to study entry

               -  Bisphosphonates may be initiated during study only for the treatment of
                  hypercalcemia