Adjuvant Chemotherapy for Elderly Non Frail Patients With an Increased Risk for Relapse of a Primary Carcinoma of the Breast

Exclusion Criteria

• •1. Known hypersensitivity reaction to the compounds or incorporated substances or known dihydropyrimidine dehydrogenase deficiency.
• •2. Low risk patient according to risk assessment.
• •3. Inadequate organ function including:
• •Leucocytes \< 3,5 G/l, Platelets \< 100 G/l , Creatinine or Bilirubin above normal limits (1,25 above upper normal limit), Creatinine-Clearance below 50 ml/min, uncompensated cardiac function, severe and relevant co-morbidity that would interact with the application of cytotoxic agents or the participation in the study.
• •4. Previously or currently one of the following medical conditions:
• •* pre-existing motor or sensory neuropathy of a severity \>= grade 2 by NCI-CTC criteria;
• •* history of significant neurological or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent;
• •* known or suspected congestive heart failure (\> NYHA I) and/or coronary heart disease, angina pectoris requiring antianginal medication, previous history of myocardial infarction, evidence of transmural infarction on ECG, un- or poorly controlled arterial hypertension (i.e. BP \>150/100 mmHg under treatment with two antihypertensive drugs), rhythm abnormalities requiring permanent treatment, clinically significant valvular heart disease;
• •* Creatinine Clearance less than 50 ml/min;
• •* another primary malignancy with an event-free survival of \< 5 years, except curatively treated basalioma of the skin and carcinoma in situ of the cervix.
• •5. Time since axillary dissection \> 3 months.
• •6. Locally advanced, non-operable breast cancer.
• •7. Previous invasive breast carcinoma.
• •8. Prior chemotherapy for any malignancy.
• •9. Concurrent specific systemic anti-tumor treatment or treatment with experimental compounds within the last 6 months.
• •10. Concurrent treatment with other tumor specific experimental drugs. Participation in another clinical trial with any investigational not marketed drug.
• •11. Concurrent treatment with virostatic agents like sorivudine or analogues like brivudine, concurrent treatment with aminoglycosides, anticoagulants: heparin, warfarin as well as acetylic acid (e.g. Aspirin®) at a dose of \> 325mg/day or clopidogrel at a dose of \> 75 mg/day).