Status:
COMPLETED
A Study of Docetaxel Monotherapy or DOXIL and Docetaxel in Patients With Advanced Breast Cancer
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
The purpose of the study is to evaluate whether the time to progression for the DOXIL and docetaxel combination therapy group was superior to that of the group treated with docetaxel monotherapy in pa...
Detailed Description
This is a randomized (the study medication is assigned by a random order), active control (study medication will be compared with available standard care of treatment), parallel-group (each treatment ...
Eligibility Criteria
Inclusion
- Females with locally advanced or metastatic breast cancer who received prior anthracycline therapy in the neoadjuvant or adjuvant setting, and had at least a 12-month disease-free interval since the end of their last cytotoxic therapy, were eligible for the study
- Participants who received prior hormonal therapy, or no more than 1 cytotoxic chemotherapy regimen (anthracyclines, taxanes, or antitubulin agents were not permitted), or both for advanced disease
- Participants with normal cardiac function, as evidenced by a normal left ventricular ejection fraction
Exclusion
- More than 1 prior cytotoxic chemotherapy regimen for advanced breast cancer
- Treatment of advanced breast cancer with an anthracycline, paclitaxel, docetaxel, vinorelbine, or vinblastine (prior treatment of advanced breast cancer with 1 regimen that included alkylating agents or antimetabolite agents was acceptable)
- Less than 2 months since the last dose of trastuzumab
- Less than 3 weeks since last dose of tamoxifen or fulvestrant, or less than 1 week since the last dose of other hormonal therapy
- Radiation to areas of disease within 30 days before study enrollment
- History of New York Heart Association Class II or greater cardiac disease or other clinical evidence of congestive heart failure
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
751 Patients enrolled
Trial Details
Trial ID
NCT00091442
Start Date
September 1 2004
End Date
December 1 2008
Last Update
April 21 2014
Active Locations (147)
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1
Hoover, Alabama, United States
2
Fountain Valley, California, United States
3
Long Beach, California, United States
4
Los Angeles, California, United States