Status:
TERMINATED
Epirubicin and Docetaxel in the Treatment of Patients With Metastatic Breast Cancer
Lead Sponsor:
SCRI Development Innovations, LLC
Collaborating Sponsors:
Aventis Pharmaceuticals
Pharmacia and Upjohn
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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 effect...
Detailed Description
Upon determination of eligibility, all patients will receive: Docetaxel + Epirubicin Both drugs will be repeated at 21-day intervals
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2001
Trial Type :
INTERVENTIONAL
End Date :
October 1 2004
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT00193024
Start Date
September 1 2001
End Date
October 1 2004
Last Update
May 3 2011
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