Randomized Comparison of a Preoperative, Dose-Intensified, Interval-Shortened, Sequential Chemotherapy With Epirubicin, Paclitaxel and CMF ± Darbepoetin Alfa Versus a Preoperative, Sequential Chemotherapy With Epirubicin and Cyclophosphamide Followed by Paclitaxel in Standard Dosage ± Darbepoetin Alfa in Patients With Primary Breast Cancer
Inclusion Criteria:
- Histologically confirmed breast cancer: at least three fast biopsies.
- Primary tumor ≥2 cm acc. to clinical measurement or manifestation of an inflammatory
breast cancer.
- No systemic metastasis, exclusion by chest x-ray, sonogram of the upper abdomen and
skeletal scintiscan.
- Age ≥18 years and ≤65 years.
- ECOG < 2/WHO 0-1
- Adequate organ function defined as SGOT and bilirubin ≤ 1.5× upper limit WBC ≥ 3000
/µL Neutrophils ≥ 1000 /µL Platelets ≥ 100,000 /µL Serum creatinine < 2.0 mg/dL
- Unremarkable heart echo
- No florid hepatitis
- Written consent to participate in the treatment optimization protocol
Exclusion Criteria:
- Multicentricity in various quadrants (contact the study office)
- Known allergy to E. coli-produced medication
- Known allergy to medication containing cremophor (e.g., cyclosporin A)
- Patients receiving immunosuppressant therapy
- Lack of consent after informing the patient
- Lack of willingness to keep and disclose personal medical data as part of the study
- Pregnancy, nursing
- Secondary malignancy, excluding basalioma of the skin or carcinoma in situ of the
cervix that has received curative therapy
- Pre-existing treatment-resistant cardiac disease, coronary heart disease,
arrhythmias, cardiac insufficiency
- Patients with uncontrolled hypertension (diastolic >95 mmHg)
- A history of convulsions
- Known hypersensitivity to darbepoetin alfa or any of its other ingredients or a known
hypersensitivity to r-HuEPO