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

Last updated: May 2, 2011
Sponsor: SCRI Development Innovations, LLC
Overall Status: Terminated

Phase

2

Condition

Breast Cancer

Cancer

Treatment

N/A

Clinical Study ID

NCT00193024
SCRI BRE 39
378-ONC-0030-219
GIA 11168
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

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

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 willdetermine if you meet all of the criteria. If you do not qualify for the trial, studypersonnel will explain the reasons. If you do qualify, study personnel will explain thetrial in detail and answer any questions you may have.

Study Design

Total Participants: 90
Study Start date:
September 01, 2001
Estimated Completion Date:
October 31, 2004

Study Description

Upon determination of eligibility, all patients will receive:

Docetaxel + Epirubicin

Both drugs will be repeated at 21-day intervals