Clinical trial NCT00316875 (phase 1, status: completed)
Conditions: breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: lapatinib ditosylate, doxil
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=CC2=C1C(=O)C1=C(O)C3=C(C[C@](O)(C[C@@H]3O[C@H]3C[C@H](N)[C@H](O)[C@H](C)O3)C(=O)CO)C(O)=C1C2=O
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed adenocarcinoma of the breast with evidence of metastatic
             disease

               -  Epidermal growth factor receptor (EGFR) and/or erbB2 positivity not required

          -  Measurable disease, defined as ≥ 1 lesion that can be accurately measured in ≥ 1
             dimension as ≥ 20 mm by conventional techniques OR as ≥ 10 mm by spiral CT scan

          -  No known brain metastases or leptomeningeal disease

          -  Hormone receptor status not specified

        PATIENT CHARACTERISTICS:

          -  Male or female patients

          -  Menopausal status not specified

          -  Life expectancy ≥ 12 weeks

          -  ECOG performance status 0-1

          -  WBC ≥ 3,000/mm^3

          -  Absolute neutrophil count ≥ 1,500/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  Bilirubin normal

          -  AST/ALT ≤ 2.5 times upper limit of normal

          -  Creatinine normal OR creatinine clearance ≥ 60 mL/min

          -  LVEF ≥ 50%

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  Able to swallow and retain oral medication

          -  No history of allergic reactions attributed to compounds of similar chemical or
             biologic composition to lapatinib

          -  No gastrointestinal (GI) tract disease resulting in inability to take oral medication

          -  No malabsorption syndrome or requirement for IV alimentation

          -  No uncontrolled inflammatory GI disease (e.g., Crohn's disease, ulcerative colitis)

        PRIOR CONCURRENT THERAPY:

          -  Prior trastuzumab (Herceptin ®) allowed

          -  Prior anthracyclines allowed provided total dose of doxorubicin hydrochloride ≤ 240
             mg/m² or epirubicin ≤ 600 mg/m²

          -  More than 4 weeks since prior major surgery, hormonal therapy (other than replacement
             therapy), chemotherapy (6 weeks for nitrosoureas or mitomycin C), or radiotherapy and
             recovered

          -  No prior surgical procedures affecting absorption

          -  No prior EGFR-targeting therapies

          -  At least 7 days since prior and no concurrent CYP3A4 inhibitors

          -  At least 7 days since prior and no concurrent gastric pH modifiers

               -  Antacids allowed within 1 hour before and after lapatinib dosing

          -  At least 14 days since prior and no concurrent CYP3A4 inducers, including
             dexamethasone or dexamethasone equivalent dose > 1.5 mg/day

          -  At least 6 months since prior and no concurrent amiodarone

          -  No concurrent combination antiretroviral therapy for HIV-positive patients

          -  No concurrent prophylactic growth factor support

          -  No concurrent herbal medications

          -  No other concurrent investigational agents or anticancer therapy