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

• Status: Completed
• Trial end date: 2009-07-01
• Target enrollment: 0
• Participant gender: Female

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 cyPhase: Phase 3Accepts Healthy Volunteers? No

Details

• Lead Sponsor: North Eastern German Society of Gynaecological Oncology; North Eastern Germany Society of Gynaecologic Oncology
• Treatments: Albumin-Bound Paclitaxel; Cyclophosphamide; Epirubicin; Lenograstim; Paclitaxel

Criteria

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