Breast Cancer
Conditions
Keywords
breast cancer with 1-3 afflicted axillary lymph nodes
Brief summary
The purpose of this study is to determine whether a treatment with 4 cycles anthracycline + cyclophoshamide followed by administration of 4 cycles paclitaxel is more effective than therapy with 4 cy\<cles of anthracycline adminbistration followed by 4 cycles of paclitaxel
Interventions
DRUGCyclophosphamide, Epirubicin, Paclitaxel
4 cycles of 600 mg/m² cyclophosphamide i.v. and 90 mg/m2 Farmorubicin i.v. on day 1, q21d followed by 4 cycles of 175 mg/m² Taxol, day 1, q21d
DRUGEpirubicin, Paclitaxel, Filgrastim
cycle 1-4: 120 mg/m² Epirubicin i.v. on day 1, q14d, 5 µg/kg s.c. filgrastim day 5-10 (if leucocytes are lower than 10000/µl) cycle 5-8: 175 mg/m² Paclitaxel i.v. on day 1, q14d, 5 µg/kg s.c. filgrastim day 5-10 (if leucocytes are lower than 10000/µl)
Sponsors
North Eastern German Society of Gynaecological Oncology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* women with histologically proven breast cancer (pT1/pT2/pT3, pN1, N0) * ECOG performance status 0-1 * start of adjuvant therapy not later than 4 weeks after surgery * hematology: platelets at least 100xGpt/l, neutrophiles at least 2xGpt/l * normal liver function as defined by: bilirubine till 1.5 x normal value, SGOT/SGPT till 1.25 x normal value * normal kidney function as defined by: creatine till 1.5 x normal value * negative pregnancy test for patients before menopause and effective contraception * written informed consent
Exclusion criteria
* prior radiation, chemotherapy, hormontherapy and immunotherapy * patients with more than 3 afflicted lymph nodes * afflicted lymph nodes on the cantralateal side and/or afflicted supraclavicular or intraclavicular lymph nodes * bilateral breast cancer or second carcinoma of the breast * inflammatory breast cancer and/or distant metastases * existing clinically relevant peripheral neuropathie * heart infection during the last 6 months or therapeutically not compensated heart failure or cardiac arrhythmias of at least LOWN II * patients with active infections and/or not controlled hypercalcemia * pregnant or breastfeeding women or women of child-bearing age who do not use effictive contrazeptiva
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free time | every 3-6 months |
Secondary
| Measure | Time frame |
|---|---|
| toxicity | — |
| overall survival | 5 years |
Countries
Germany
Outcome results
None listed