Clinical Trials Directory

Trials / Completed

CompletedNCT00303108

Doxil & Carboplatin Plus HER2+ in Metastatic Breast Cancer

Phase II Study of Doxil and Carboplatin, Plus Herceptin in HER2+ Patients, in Metastatic Breast Cancer

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
136 (actual)
Sponsor
US Oncology Research · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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).

Conditions

Interventions

TypeNameDescription
DRUGPegylated liposomal doxorubicin30 mg/m2 IV on Day 1 of each 28 day cycle
DRUGCarboplatinAUC=5 on Day 1 of each 28 day cycle
DRUGtrastuzumab4 mg/kg on Days 1 and 15 of each cycle(loading dose of 8 mg/kg on Day 1 of Cycle 1 only)

Timeline

Start date
2005-12-01
Primary completion
2010-03-01
Completion
2011-06-01
First posted
2006-03-15
Last updated
2016-11-03
Results posted
2016-11-03

Locations

57 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00303108. Inclusion in this directory is not an endorsement.