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

Phase 3

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Cyclophosphamide, Epirubicin, Paclitaxel; Drug: Epirubicin, Paclitaxel, Filgrastim

• Registration Number: NCT00668616
• Lead Sponsor: North Eastern German Society of Gynaecological Oncology

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

Detailed Description

Not available

Study Timeline

• Study Start: 2000-03
• Primary Completion: 2005-07
• Study First Submitted: 2008-04-25
• Study First Submitted QC: 2008-04-28
• Study First Posted: 2008-04-29
• Study Completion: 2009-07
• Status Verified: 2010-07
• Last Update Submitted: 2010-07-28
• Last Update Posted: 2010-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1034

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Cyclophosphamide, Epirubicin, Paclitaxel	-
2	Epirubicin, Paclitaxel, Filgrastim	-

Primary Outcome Measures

Name	Time	Method
progression-free time	every 3-6 months

Secondary Outcome Measures

Name	Time	Method
toxicity
overall survival	5 years

Trial Locations

Locations (1)

Oskar-Ziethen-Krankenhaus; 🇩🇪 Berlin, Germany