Clinical trial NCT00093808 (phase 2, status: completed)
Conditions: breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: capecitabine, vinorelbine tartrate
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, [H][C@@]12N(C)C3=CC(OC)=C(C=C3[C@@]11CCN3CC=C[C@](CC)([C@@]13[H])[C@@]([H])(OC(C)=O)[C@]2(O)C(=O)OC)[C@]1(C[C@@]2([H])CN(CC(CC)=C2)CC2=C1NC1=CC=CC=C21)C(=O)OC
Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically or cytologically confirmed invasive breast cancer

               -  Metastatic disease

          -  HER2/neu-positive by immunohistochemistry (3+ by HercepTest^™ or equivalent) OR
             positive for amplification by fluorescent in situ hybridization

               -  Testing may be performed in the primary tumor or the metastatic site

          -  Received prior anthracycline or taxane as adjuvant therapy or for metastatic disease

          -  Measurable disease

               -  At least one measurable lesion ≥ 2.0 cm by CT scan or MRI OR ≥ 1.0 cm by spiral
                  CT scan

               -  The following are considered non-measurable disease:

                    -  Bone lesions

                    -  Leptomeningeal disease

                    -  Ascites

                    -  Pleural/pericardial effusion

                    -  Inflammatory breast disease

                    -  Lymphangitis cutis/pulmonis

                    -  Abdominal masses that are not confirmed and followed by imaging techniques

                    -  Cystic lesions

          -  No bone metastases as the only evidence of metastasis

          -  Previously treated CNS metastases allowed provided disease has been stable for ≥ the
             past 3 months

          -  Hormone receptor status:

               -  Not specified

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Sex

          -  Female or male

        Performance status

          -  ECOG 0-2

        Life expectancy

          -  At least 12 weeks

        Hematopoietic

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

          -  Hemoglobin ≥ 8.0 g/dL

          -  Platelet count ≥ 100,000/mm^3

          -  No known uncontrolled coagulopathy

        Hepatic

          -  Bilirubin ≤ 3.0 times the upper limit of normal (ULN)

          -  One of the following must be true:

               -  AST or ALT ≤ 5 times ULN AND alkaline phosphatase normal

               -  Alkaline phosphatase ≤ 5 times ULN AND AST or ALT normal

               -  Alkaline phosphatase ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN

          -  INR ≤ 1.5 times ULN

        Renal

          -  Calcium ≤ 11.5 mg/dL

          -  Creatinine ≤ 1.5 times ULN

          -  Creatinine clearance ≥ 30 mL/min

        Cardiovascular

          -  LVEF ≥ 50% by MUGA or echocardiogram

          -  No clinically significant (i.e., active) cardiac disease

          -  No congestive heart failure

          -  No symptomatic coronary artery disease

          -  No myocardial infarction within the past 12 months

          -  No cardiac arrhythmia not controlled with medication

        Gastrointestinal

          -  Able to take oral medication

          -  No lack of physical integrity of the upper gastrointestinal tract

          -  No clinically significant malabsorption syndrome

        Other

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for 30 days after study
             participation

          -  No history of allergy or hypersensitivity to study drugs, drug product excipients,
             including polysorbate 80, or chemically similar agents

          -  No prior unanticipated severe reaction to fluoropyrimidine therapy

          -  No know hypersensitivity to fluorouracil

          -  No known dihydropyrimidine dehydrogenase deficiency

          -  No history of uncontrolled seizures or CNS disorders

          -  No clinically significant psychiatric disability that would preclude giving informed
             consent or study compliance

          -  No other serious uncontrolled infection or disease

          -  No other malignancy within the past 5 years except cured basal cell skin cancer,
             carcinoma in situ of the cervix, or contralateral breast cancer

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  Prior adjuvant trastuzumab (Herceptin^®) allowed as adjuvant or first-line therapy for
             metastatic disease

          -  No concurrent immunotherapy

        Chemotherapy

          -  See Disease Characteristics

          -  No more than 1 prior chemotherapy regimen in the advanced or metastatic (non-adjuvant)
             setting

          -  No prior continuous (≥ 24 hours) fluorouracil infusion

          -  No prior capecitabine

          -  No prior oral fluoropyrimidines (e.g., eniluracil and fluorouracil, uracil and
             tegafur, S1, or emitefur)

        Endocrine therapy

          -  At least 1 day since prior hormonal therapy

          -  No concurrent hormonal therapy

        Radiotherapy

          -  More than 4 weeks since prior radiotherapy to the axial skeleton (i.e., skull, spinal
             column, sternum, or ribs)

          -  No concurrent radiotherapy

        Surgery

          -  More than 4 weeks since prior major surgery

          -  No prior organ allografts requiring immunosuppressive therapy

        Other

          -  More than 4 weeks since prior investigational drugs

          -  No concurrent sorivudine or its chemically related analogues (e.g., brivudine)

          -  No concurrent allopurinol, metronidazole, or cimetidine

          -  No other concurrent cytotoxic agents

          -  No other concurrent investigational drugs

          -  No other concurrent anticancer therapy