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

North Eastern German Society of Gynaecological Oncology

Status and phase

Completed

Phase 3

Conditions

Breast Cancer

Treatments

Drug: Epirubicin, Paclitaxel, Filgrastim

Drug: Cyclophosphamide, Epirubicin, Paclitaxel

Study type

Interventional

Funder types

Other

Identifiers

NCT00668616

170200

Details and patient eligibility

About

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

Enrollment

1,034 patients

Sex

Female

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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