At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 102 enrolled
Drug / intervention
Liposomal Doxorubicin +1 moredrug
Likely dose
Not stated in record
Key inclusion· 7
- ✓Metastatic breast cancer confirmed by biopsy
- ✓Measurable disease present
- ✓Age 18 years or older
- ✓Able to perform activities of daily living with minimal assistance
Key exclusion· 7
- ✕Prior chemotherapy for metastatic breast cancer
- ✕Pre-existing moderate peripheral neuropathy
- ✕History of significant heart disease
- ✕Meningeal metastases
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Randomized Crossover Study Doxorubicin HCI Liposome Injection Versus Weekly Docetaxel in Patients First Relapse Metastatic Breast Cancer
In Brief
A Phase 2 clinical trial evaluating Liposomal Doxorubicin and Docetaxel for Breast Cancer. Completed, enrolled 102 participants across 1 site.
Detailed 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 the opposite arm at disease progression or patient intolerance. We will explore this as well as any possible cross resistance between these two agents.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States
CollaboratorsOrtho Biotech, Inc., Aventis Pharmaceuticals
Timeline
Phase 2CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2001
First PostedSep 2005
Primary CompletionDec 2008
Study CompletionNov 2009
TodayJul 2026
First PostedSep 19, 2005
Enrollment StartFeb 1, 2001
Primary CompletionDec 1, 2008
Study CompletionNov 1, 2009
TodayJul 2, 2026
Enrollment to primary: 7.8 yearsPosted 20.8 years ago
Interventions
Liposomal Doxorubicindrug
Liposomal Doxorubicin
Docetaxeldrug
Docetaxel