At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 136 enrolled
Drug / intervention
Pegylated liposomal doxorubicin +2 moredrug
Likely dose
Pegylated liposomal doxorubicin 30 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II Study of Doxil and Carboplatin, Plus Herceptin in HER2+ Patients, in Metastatic Breast Cancer
In Brief
A Phase 2 clinical trial evaluating Pegylated liposomal doxorubicin, Carboplatin, and 1 other intervention for Metastatic Breast Cancer. Completed, enrolled 136 participants across 57 sites.
Detailed Summary
The purpose of this study is to determine the ORR associated with Doxil in combination with carboplatin in HER2- (negative) MBC (and with Herceptin in HER2+ MBC).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Breast Cancer
CountriesUnited States
CollaboratorsOrtho Biotech, Inc., Tibotec Pharmaceutical Limited
Timeline
Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartDec 2005
First PostedMar 2006
Primary CompletionMar 2010
Study CompletionJun 2011
TodayJul 2026
First PostedMar 15, 2006
Enrollment StartDec 1, 2005
Primary CompletionMar 1, 2010
Study CompletionJun 1, 2011
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 20.3 years ago
Interventions
Pegylated liposomal doxorubicindrug
30 mg/m2 IV on Day 1 of each 28 day cycle
Carboplatindrug
AUC=5 on Day 1 of each 28 day cycle
trastuzumabdrug
4 mg/kg on Days 1 and 15 of each cycle(loading dose of 8 mg/kg on Day 1 of Cycle 1 only)