Epirubicin and Docetaxel in the Treatment of Patients With Metastatic Breast Cancer

A Phase II Trial of Epirubicin/Docetaxel in the First-Line Treatment of Patients With Metastatic Breast Cancer

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00193024

Enrollment

Registered

2005-09-19

Start date

2001-09-30

Completion date

2004-10-31

Last updated

2011-05-03

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

Conditions

Breast Cancer

Brief summary

The epirubicin/docetaxel combination is one of the most active and best tolerated taxane/anthracycline combinations. In this phase II trial, we will further evaluate the feasibility, safety and effectiveness of the docetaxel/epirubicin combination, when administered as first-line treatment for metastatic breast cancer.

Detailed description

Upon determination of eligibility, all patients will receive: Docetaxel + Epirubicin Both drugs will be repeated at 21-day intervals

Interventions

DRUGDocetaxel

DRUGEpirubicin

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

To be included in this study, you must meet the following criteria: * Metastatic breast cancer confirmed by biopsy. * Received no previous chemotherapy for metastatic breast cancer. * Prior hormonal therapy is acceptable. * Measurable or evaluable disease. * Able to perform activities of daily living without considerable assistance * Adequate bone marrow, liver and kidney function * Must be able to understand the nature of this study and give written informed consent.

Exclusion criteria

You cannot participate in this study if any of the following apply to you: * Age \< 18 years. * Cardiac ejection fraction \< 45%. * Women who are pregnant or lactating. * Patients with meningeal metastases are ineligible. * Moderate peripheral neuropathy * History of hypersensitivity reaction to Taxotere * Males with metastatic breast cancer Please note: There are additional inclusion/

Design outcomes

Primary

Measure	Time frame
Clinical response rate of the docetaxel/epirubicin combination in the first-line treatment of patients with metastatic breast cancer	—

Secondary

Measure	Time frame
Safety of the docetaxel/epirubicin combination in the first-line treatment of patients with metastatic breast cancer	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026