Status:
COMPLETED
Doxorubicin HCI Liposome Injection Versus Weekly Docetaxel in Patients First Relapse Metastatic Breast Cancer
Lead Sponsor:
SCRI Development Innovations, LLC
Collaborating Sponsors:
Ortho Biotech, Inc.
Aventis Pharmaceuticals
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The efficacy of single agent liposomal doxorubicin as compared to single agent docetaxel will be evaluated as first line treatment in metastatic breast cancer patients, with subsequent crossover to th...
Detailed Description
Upon determination of eligibility, patients will be randomly assigned to one of two treatment arms: * Liposomal Doxorubicin * Docetaxel For ever 2 patients treated, 1 will receive treatment A (Lipos...
Eligibility Criteria
Inclusion
- To be included in this study, you must meet the following criteria:
- Metastatic breast cancer confirmed by biopsy
- Prior adjuvant/neoadjuvant treatment allowed
- Measurable disease
- Able to perform activities of daily living with minimal assistance
- Age 18 years or older
- Adequate bone marrow, liver and kidney function
- Normal heart function
- Written informed consent
Exclusion
- You cannot participate in this study if any of the following apply to you:
- Pre-existing moderate peripheral neuropathy
- History of significant heart disease
- Meningeal metastases.
- Prior chemotherapy for metastatic breast cancer
- No measurable disease (including bone only, pleural effusions, etc.)
- Receiving Herceptin therapy.
- Women who are pregnant or lactating.
- 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 :
February 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT00193037
Start Date
February 1 2001
End Date
November 1 2009
Last Update
July 31 2013
Active Locations (1)
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1
Tennessee Oncology
Nashville, Tennessee, United States, 37203