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

Breast Cancer Clinical Trial

Official title:

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+)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00668616
• Other study ID #: 170200
• Status: Completed
• Phase: Phase 3
• First received: April 25, 2008
• Last updated: July 28, 2010
• Start date: March 2000
• Est. completion date: July 2009

Study information

• Verified date: July 2010
• Source: North Eastern Germany Society of Gynaecologic Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1034
• Est. completion date: July 2009
• Est. primary completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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
• 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)

Locations

Country	Name	City	State
Germany	Oskar-Ziethen-Krankenhaus	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
North Eastern Germany Society of Gynaecologic Oncology

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression-free time		every 3-6 months	No
Secondary	toxicity			Yes
Secondary	overall survival		5 years	No