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

NCT ID: NCT00668616

Last Updated: 2010-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1034 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-03-31
• Study Completion Date: 2009-07-31

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

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: ACTIVE_COMPARATOR

Cyclophosphamide, Epirubicin, Paclitaxel

Intervention Type: DRUG

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

2

Group Type: EXPERIMENTAL

Epirubicin, Paclitaxel, Filgrastim

Intervention Type: DRUG

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)

Interventions

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

Intervention Type: 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)

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

North Eastern German Society of Gynaecological Oncology

OTHER

Sponsor Role: lead

Locations

Oskar-Ziethen-Krankenhaus

Berlin, State of Berlin, Germany

Countries

Germany

Other Identifiers

170200

Identifier Type: -

Identifier Source: org_study_id