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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2011 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-06-30

Study Completion Date

2010-08-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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EC-Doc

4 cycles epirubicin + docetaxel (90/600) i.v., q = 3 weeks, followed by 4 cycles docetaxel (100) i.v., q = 3 weeks

Group Type EXPERIMENTAL

Epirubicin

Intervention Type DRUG

Cyclophosphamide

Intervention Type DRUG

Docetaxel

Intervention Type DRUG

CMF/CEF

6 cycles cyclophosphamide, methotrexate, 5-fluorouracil (CMF) (600/40/600) i.v., day 1 + 8, q = 4 weeks or 6 cycles cyclophosphamide, epirubicin, 5-fluorouracil (CEF) (500/100/500) i.v., day 1, q = 3 weeks

Group Type ACTIVE_COMPARATOR

Epirubicin

Intervention Type DRUG

Cyclophosphamide

Intervention Type DRUG

Methotrexate

Intervention Type DRUG

5-fluorouracil

Intervention Type DRUG

Interventions

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Epirubicin

Intervention Type DRUG

Cyclophosphamide

Intervention Type DRUG

Docetaxel

Intervention Type DRUG

Methotrexate

Intervention Type DRUG

5-fluorouracil

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No