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
  Purpose

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 Intervention Phase
Breast Cancer
Drug: Docetaxel
Drug: Epirubicin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by SCRI Development Innovations, LLC:

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

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

Estimated Enrollment: 90
Study Start Date: September 2001
Study Completion Date: October 2004
Primary Completion Date: October 2003 (Final data collection date for primary outcome measure)
Detailed Description:

Upon determination of eligibility, all patients will receive:

Docetaxel + Epirubicin

Both drugs will be repeated at 21-day intervals

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00193024

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

Additional Information:
Publications:
Responsible Party: SCRI Oncology Research Consortium, SCRI
ClinicalTrials.gov Identifier: NCT00193024     History of Changes
Other Study ID Numbers: SCRI BRE 39, 378-ONC-0030-219, GIA 11168
Study First Received: September 12, 2005
Last Updated: May 2, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 19, 2014