Clinical trial NCT00130507 (phase 2, status: terminated)
Conditions: breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: vinorelbine, capecitabine, trastuzumab
SMILES: [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, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1
Reason stopped: 
    a new alternative treatment caused the decrease in the rhythm of recruitment.
  
Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent.

          -  Women older than 18 years old.

          -  HER2 positive breast cancer with histological diagnoses.

          -  Non-operable locally advanced or metastatic disease, previously treated with
             trastuzumab and taxanes.

          -  Measurable or non-measurable disease as per Response Evaluation Criteria in Solid
             Tumors (RECIST).

          -  Disease progression during or after treatment with trastuzumab and taxanes.

          -  Maximum of 1 previous chemotherapy line for advanced or metastatic disease.

          -  Previous radiotherapy is allowed if radiated area is not the only documented lesion.

          -  At least 4 weeks since the last administration of antineoplastic treatment and all
             toxicities resolved.

          -  Performance status Eastern Cooperative Oncology Group (ECOG) >=2.

          -  Life expectancy of at least 12 weeks.

          -  Left Ventricular Ejection Fraction (LVEF) evaluation (>=50%) in previous 4 weeks.

          -  Hematology:

               -  neutrophils >=1.5 x 10e9/l;

               -  platelets >= 100 x 10e9/l;

               -  hemoglobin >= 10 mg/dl

          -  Hepatic function:

               -  total bilirubin <= 1.5 x under normal limit (UNL);

               -  Aspartate aminotransferase (SGOT) and Alanine aminotransferase (SGPT) and
                  alkaline phosphatase <= 2.5 x UNL, or <=5 x UNL if hepatic lesions present

          -  Renal function:

               -  creatinine <= 175 µmol/l (2 mg/dl);

               -  creatinine clearance >= 60 ml/min.

          -  Patients able to comply with treatment and follow-up.

          -  Negative pregnancy test in the previous 14 days. Adequate contraceptive method during
             treatment and up to 3 months after finalised.

          -  Brain metastatic lesions are allowed provided all other criteria are met.

          -  Male who met inclusion criteria are eligible.

        Exclusion Criteria:

          -  History of hypersensitivity to vinorelbine, trastuzumab, rat proteins or trastuzumab
             components.

          -  History of dyspnea at rest, or chronic oxygen therapy required.

          -  Active infection.

          -  Second malignancy, except for cervical in situ carcinoma, basal skin carcinoma,
             adequately treated. Previous malignancies with a 5 year disease free survival are
             allowed.

          -  Pregnant or lactating women.

          -  Any other serious medical pathology, such as congestive heart failure, unstable
             angina, history of myocardial infarction during the previous year, uncontrolled
             hypertension or high risk arrhythmias.

          -  History of neurological or psychiatric disorders, which could preclude the patients to
             free informed consent.

          -  Active uncontrolled infection.

          -  Active peptic ulcer, unstable diabetes mellitus.

          -  Concomitant treatment with other investigational products. Participation in other
             clinical trials with a non-marketed drug in the 30 previous days before randomization.

          -  Concomitant treatment with other therapy for cancer.