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

This study has been terminated.
Sponsor:
Collaborators:
Aventis Pharmaceuticals
Pharmacia and Upjohn
Information provided by:
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT00193024
First received: September 12, 2005
Last updated: May 2, 2011
Last verified: May 2011

September 12, 2005
May 2, 2011
September 2001
October 2003   (final data collection date for primary outcome measure)
Clinical response rate of the docetaxel/epirubicin combination in the first-line treatment of patients with metastatic breast cancer
Same as current
Complete list of historical versions of study NCT00193024 on ClinicalTrials.gov Archive Site
Safety of the docetaxel/epirubicin combination in the first-line treatment of patients with metastatic breast cancer
Same as current
Not Provided
Not Provided
 
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

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.

Upon determination of eligibility, all patients will receive:

Docetaxel + Epirubicin

Both drugs will be repeated at 21-day intervals

Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • Drug: Docetaxel
  • Drug: Epirubicin
Not Provided
Hainsworth JD, Yardley DA, Spigel DR, Meluch AA, Rinaldi D, Schnell FM, Greco FA. Docetaxel and epirubicin as first-line treatment for patients with metastatic breast cancer: a Minnie Pearl Cancer Research Network Phase II trial. Cancer Invest. 2006 Aug-Sep;24(5):469-73.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
90
October 2004
October 2003   (final data collection date for primary outcome measure)

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.

Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00193024
SCRI BRE 39, 378-ONC-0030-219, GIA 11168
Not Provided
SCRI Oncology Research Consortium, SCRI
SCRI Development Innovations, LLC
  • Aventis Pharmaceuticals
  • Pharmacia and Upjohn
Principal Investigator: John D. Hainsworth, MD SCRI Development Innovations, LLC
SCRI Development Innovations, LLC
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP