Clinical trial NCT00114816 (phase 3, status: completed)
Conditions: breast cancer
ICD codes: C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: capecitabine, docetaxel
SMILES: [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
Eligibility criteria:

        Inclusion Criteria:

        To be eligible for inclusion in the study, each patient must fulfill each of the criteria
        below.

          -  Have provided written informed consent prior to study-specific screening procedures,
             with the understanding that the patient has the right to withdraw from the study at
             any time, without prejudice.

          -  Be female and 18 years of age or older.

          -  Have histologically confirmed invasive breast cancer.

          -  High risk of breast cancer recurrence (> 25% within the first 5 years without adjuvant
             therapy, > 35% within the first 10 years) with one of the following:

               -  Regional node positive disease (pN+; tumor cells or tumor cell clusters < 0.2 mm
                  in diameter are not counted as metastases);

               -  Pathological N0 and PgR- and tumor size > 20 mm.

        Exclusion Criteria:

        Patients who fulfill any of the following criteria will be excluded:

          -  > 65 years of age.

          -  "Special type" histology (mucinous, papillary, medullary, or tubular breast cancer),
             when pN0.

          -  ER, PgR and HER-2 status (via in situ hybridization or immunohistochemistry) not
             determined.

          -  Presence of distant metastases.

          -  Previous chemotherapy in the neoadjuvant setting.

          -  Non-ambulatory or WHO performance status > 1.

          -  Pregnant or lactating women. Women of childbearing potential (menstruating within 6
             months of study entry or with no hysterectomy and age < 55) with either a positive or
             no pregnancy test at baseline.

          -  Women of childbearing potential unless using a reliable and appropriate contraceptive
             method. (Post-menopausal women must have been amenorrheic for at least 6 months to be
             considered of non-childbearing potential).

          -  More than 12 weeks between breast surgery and date of randomization.

          -  Organ allografts with immunosuppressive therapy required.

          -  Major surgery (except breast surgery) within 4 weeks prior to study treatment start,
             or lack of complete recovery from the effects of major surgery.

          -  Participation in any investigational drug study within 4 weeks preceding treatment
             start.

          -  Patients with a history of uncontrolled seizures, central nervous system disorders or
             psychiatric disability judged by the investigator to be clinically significant
             precluding informed consent or interfering with compliance for oral drug intake.

          -  History of another malignancy within the last five years except cured basal cell
             carcinoma of skin or carcinoma in situ of the uterine cervix.

          -  Clinically significant (i.e. active) cardiac disease (e.g. congestive heart failure,
             symptomatic coronary artery disease and cardiac arrhythmia not well controlled with
             medication) or myocardial infarction within the last 12 months.

          -  Abnormal laboratory values:

               -  Hemoglobin < 10.0 g/dL, neutrophils < 1.5 x 10^9/L, platelet count < 120 x
                  10^9/L;

               -  Serum creatinine > 1.5 x Upper Limit of Normal (ULN);

               -  Creatinine clearance (calculated per Cockroft and Gault) < 50 mL/min;

               -  Serum bilirubin > ULN;

               -  ALAT > 1.5 x ULN;

               -  Alkaline phosphatase > 2.5 x ULN.

          -  Serious uncontrolled intercurrent infections or other serious uncontrolled concomitant
             disease.

          -  Lack of physical integrity of the upper gastrointestinal tract or those who have
             clinically significant malabsorption syndrome.

          -  Inability to swallow tablets.

          -  Life expectancy of less than 3 months.

          -  Unwilling or unable to comply with the protocol for the duration of the study.

          -  Requirement for concurrent use of the antiviral agent sorivudine or chemically related
             analogues, such as brivudine.