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

Phase 2

Terminated

• Conditions: Breast Cancer

• Registration Number: NCT00193024
• Lead Sponsor: SCRI Development Innovations, LLC

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

Study Timeline

• Study Start: 2001-09
• Primary Completion: 2003-10
• Study Completion: 2004-10
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-19
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-02
• Last Update Posted: 2011-05-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 90

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/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Safety of the docetaxel/epirubicin combination in the first-line treatment of patients with metastatic breast cancer