4 x Epirubicin, Cyclophosphamide, Followed by 4 x Docetaxel Versus 6 x CMF / 6 x CEF

West German Study Group2,011 enrolled

Overview

Taxane-based adjuvant chemotherapy is standard in node-positive (N+) early breast cancer (BC). The magnitude of benefit in intermediate-risk N+ early BC is still unclear. West German Study Group and "Arbeitsgemeinschaft Gynäkologische Onkologie" (WSG-AGO) EC-Doc is a large trial evaluating modern sequential taxane-based chemotherapy in the subgroup with 1-3 involved lymph nodes (LN).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

2,011

Conditions

Breast Cancer

Interventions

EpirubicinDRUG

CyclophosphamideDRUG

DocetaxelDRUG

MethotrexateDRUG

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Female patients * Age 18-65 years * Eastern Cooperative Oncology Group (ECOG) status \< 2 * Surgery: R0-resection and \>= 10 removed axillary lymph nodes * M0 by chest x-ray, bone scintigraphy and liver sonography Exclusion Criteria: * Polyneuropathy * Creatinin (serum) \> 1,4 mg/dl; Bilirubin (serum) \> 2,0 mg/dl * Cardia dysfunction, ejection fraction \< lower normal value of each institution * Hematopoeitic insufficiency: leucocytes \< 3,5 G/l, thrombocytes \< 100 G/l * second malignant neoplasia, except curatively treated basalioma of the skin * Surgery before more the six weeks (42 days) * Concurrent pregnancy; patients of childbearing potential must implement a highly effective (less than 1% failure rate) non-hormonal contraceptive measures during the study treatment * Breast feeding woman * Sequential breast cancer * Reasons indicating risk of poor compliance * Patients not able to consent

Locations (1)

Ev. Hospital Bethesda

Mönchengladbach, Germany