Clinical trial NCT00424164 (phase 1, status: unknown status)
Conditions: breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: lapatinib ditosylate, tamoxifen citrate
SMILES: CS(=O)(=O)CCNCC1=CC=C(O1)C1=CC2=C(C=C1)N=CN=C2NC1=CC(Cl)=C(OCC2=CC(F)=CC=C2)C=C1, COC1=CC(NCC2=C(C)C3=C(C=C2)N=C(N)N=C3N)=CC(OC)=C1OC
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed advanced or metastatic breast cancer

               -  Progressive disease after aromatase inhibitor therapy

          -  Hormone receptor status:

               -  Estrogen receptor- and/or progesterone receptor-positive tumor

          -  Patients with stable brain metastases (i.e., no neurological symptoms and no
             corticosteroid treatment) are eligible

        PATIENT CHARACTERISTICS:

          -  Male or female

          -  Menopausal status not specified

          -  ECOG performance status 0-2

          -  Life expectancy ≥ 12 weeks

          -  Neutrophil count > 1,500/mm³

          -  Platelet count > 100,000/mm³

          -  AST and/or ALT < 3 times upper limit of normal (ULN)

          -  Creatinine < 1.5 times ULN

          -  Bilirubin < 1.5 times ULN

          -  Clinically normal cardiac function (i.e., LVEF normal by MUGA or ECHO)

          -  No current active hepatic or biliary disease (with exception of patients with
             Gilbert's syndrome, asymptomatic gallstones, liver metastases, or stable chronic live
             disease)

          -  No ischemic heart disease within the past 6 months

          -  Normal 12-lead ECG

          -  No active or uncontrolled infections

          -  No serious illnesses or medical conditions, including any of the following:

               -  Hypercalcemia

               -  Malabsorption syndrome

               -  Chronic alcohol abuse

               -  Hepatitis

               -  HIV

               -  Cirrhosis

          -  Able to swallow and retain oral medication

          -  No psychological, familial, sociological, or geographical condition potentially
             hampering study compliance

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for 3 months after
             completion of study treatment

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  At least 2 days since prior and no concurrent inducers or inhibitors of CYP3A4,
             including any of the following:

               -  Rifabutin

               -  Clarithromycin

               -  Cyclosporine

               -  Voriconazole

               -  Fluoxetine

               -  Paroxetine

               -  Midazolam

               -  Isoniazid

               -  Dihydralazine

               -  Digitoxin

               -  Coumadin

               -  Phenytoin

               -  Verapamil

               -  Diltiazem

               -  Herbal constituents (e.g., bergamottin and glabridin)

          -  At least 2 weeks since prior aromatase inhibitor

               -  Aromatase inhibitors in the adjuvant and/or metastatic setting allowed

          -  At least 1 year since prior tamoxifen citrate

          -  No other concurrent anticancer therapy or investigational agents