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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00193024
Recruitment Status : Terminated
First Posted : September 19, 2005
Last Update Posted : May 3, 2011
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Docetaxel Drug: Epirubicin Phase 2

Detailed Description:

Upon determination of eligibility, all patients will receive:

Docetaxel + Epirubicin

Both drugs will be repeated at 21-day intervals

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Epirubicin/Docetaxel in the First-Line Treatment of Patients With Metastatic Breast Cancer
Study Start Date : September 2001
Primary Completion Date : October 2003
Study Completion Date : October 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Clinical response rate of the docetaxel/epirubicin combination in the first-line treatment of patients with metastatic breast cancer

Secondary Outcome Measures :
  1. Safety of the docetaxel/epirubicin combination in the first-line treatment of patients with metastatic breast cancer

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00193024

Sponsors and Collaborators
SCRI Development Innovations, LLC
Aventis Pharmaceuticals
Pharmacia and Upjohn
Principal Investigator: John D. Hainsworth, MD SCRI Development Innovations, LLC
More Information

Additional Information:
Responsible Party: SCRI Oncology Research Consortium, SCRI
ClinicalTrials.gov Identifier: NCT00193024     History of Changes
Other Study ID Numbers: SCRI BRE 39
GIA 11168
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: May 3, 2011
Last Verified: May 2011

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors