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

Adjuvant Chemotherapy of Breast Cancer: Sequential Chemotherapy vs. Standard Therapy. Prospective Randomised Comparison of 4 x Epirubicin and Cyclophosphamide (EC) --> 4 x Docetaxel (Doc) vs. 6 x CMF / CEF in Patients With 1 to 3 Positive Lymph Nodes

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02115204

Enrollment

2011

Registered

2014-04-15

Start date

2000-06-30

Completion date

2010-08-31

Last updated

2019-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Brief summary

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).

Interventions

DRUGEpirubicin

DRUGCyclophosphamide

DRUGDocetaxel

DRUGMethotrexate

DRUG5-fluorouracil

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Comparison of event-free survival	60 months after end of treatment

Secondary

Measure	Time frame
Comparison of overall survival	60 months after end of treatment
Comparison of toxicity (measured as number of adverse events)	60 months after end of treatment
Comparison of quality of life	60 months after end of treatment
Comparison of cost effectiveness across the applied regimens in relation to event-free survival	60 months after end of treatment

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026