An Investigational Randomized Study on Epirubicin Plus Cyclophospamide (EC) or Cyclophosphamide Plus Methotrexat Plus 5-fluorouracil (CMF) Versus Nab-paclitaxel Plus Capecitabine as Adjuvant Chemotherapy for Elderly Non Frail Patients With an Increased Risk for Relapse of a Primary Carcinoma of the Breast
1. Written informed consent for all study procedures must be obtained and documented
according to local regulatory requirements prior to beginning specific protocol
2. Complete baseline documentation must be sent to GBG Forschungs GmbH.
3. Histological confirmed unilateral or bilateral primary carcinoma of the breast.
4. Female and male breast cancer patients with age at first histologically diagnosis and
axilla dissection ≥ 65 years.
5. Adequate surgical treatment with complete resection (R0) of the tumor and ≥ 10
axillary nodes. Sole sentinel node biopsy is allowed if the sentinel node shows no
6. No evidence for distant metastasis at bone scan, liver ultrasound and chest x-ray.
7. Patients with stage pT3/4 or pN2/3 (≥ 4 involved lymph nodes) irrespective of
additional risk factors.
8. Patients with stage pT1/2 and pN0/1 (0-3 involved lymph nodes) with an increased risk
according to the clinico-pathological or uPA/PAI-1 criteria.
9. ECOG Performance Status <= 2.
10. Charlson Scale <= 2.
11. Estimated life expectancy of at least 5 years (irrespective of breast cancer
12. The patient must be accessible for treatment and follow-up. Patients registered on
this trial must be treated and followed at the participating centre which could be
the Principal or a Co- investigator's site.
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
- 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).