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
3 other identifiers
interventional
90
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 breast-cancer
Started Sep 2001
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2001
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2003
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 19, 2005
CompletedMay 3, 2011
May 1, 2011
2.1 years
September 12, 2005
May 2, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical response rate of the docetaxel/epirubicin combination in the first-line treatment of patients with metastatic breast cancer
Secondary Outcomes (1)
Safety of the docetaxel/epirubicin combination in the first-line treatment of patients with metastatic breast cancer
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- SCRI Development Innovations, LLClead
- Aventis Pharmaceuticalscollaborator
- Pharmacia and Upjohncollaborator
Related Publications (1)
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. doi: 10.1080/07357900600814060.
PMID: 16939953RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John D. Hainsworth, MD
SCRI Development Innovations, LLC
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 19, 2005
Study Start
September 1, 2001
Primary Completion
October 1, 2003
Study Completion
October 1, 2004
Last Updated
May 3, 2011
Record last verified: 2011-05