NCT00668616

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+)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,034 (actual)
• Sponsor: North Eastern German Society of Gynaecological Oncology · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Cyclophosphamide, Epirubicin, Paclitaxel	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
DRUG	Epirubicin, Paclitaxel, Filgrastim	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)

Timeline

• Start date: 2000-03-01
• Primary completion: 2005-07-01
• Completion: 2009-07-01
• First posted: 2008-04-29
• Last updated: 2010-07-29

Locations

1 site across 1 country: Germany