Adjuvant Treatment of Breast Cancer With 1-3 Aflicted Lymph Nodes

Cyclophosphamid + Farmorubicin® With Subsequent Administration of Taxol® (q3w) Versus Intensified Administration of Farmorubicin® Followed by Taxol® (q2w) in the Adjuvant Treatment of Breast Cancer in Patients With 1-3 Afflicted Lymph Nodes (1-3 LK+)

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

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