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

Study Overview
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Brief Summary
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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

Official Title
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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+)

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Cyclophosphamide, Epirubicin, Paclitaxel
* Drug: Epirubicin, Paclitaxel, Filgrastim


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Drug: Cyclophosphamide, Epirubicin, Paclitaxel<br>* 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<br>|
| Experimental: 2<br> | Drug: Epirubicin, Paclitaxel, Filgrastim<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression-free time |  | every 3-6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| toxicity |  |  | 
| overall survival |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer with 1-3 afflicted axillary lymph nodes