Status:
COMPLETED
Adjuvant Treatment of Breast Cancer With 1-3 Aflicted Lymph Nodes
Lead Sponsor:
North Eastern German Society of Gynaecological Oncology
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-75 years
Phase:
PHASE3
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\<...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
1034 Patients enrolled
Trial Details
Trial ID
NCT00668616
Start Date
March 1 2000
End Date
July 1 2009
Last Update
July 29 2010
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Oskar-Ziethen-Krankenhaus
Berlin, State of Berlin, Germany, 10365