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Doxil & Carboplatin Plus HER2+ in Metastatic Breast Cancer

NCT00303108 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 136

Last updated 2016-11-03

Study results available
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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

DRUG

Pegylated liposomal doxorubicin

30 mg/m2 IV on Day 1 of each 28 day cycle

DRUG

Carboplatin

AUC=5 on Day 1 of each 28 day cycle

DRUG

trastuzumab

4 mg/kg on Days 1 and 15 of each cycle(loading dose of 8 mg/kg on Day 1 of Cycle 1 only)

Sponsors & Collaborators

  • Ortho Biotech, Inc.

    collaborator INDUSTRY

  • Tibotec Pharmaceutical Limited

    collaborator INDUSTRY

  • US Oncology Research

    lead INDUSTRY

Principal Investigators

  • Rufus P Collea, MD · US Oncology Research

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-12-31
Primary Completion
2010-03-31
Completion
2011-06-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00303108 on ClinicalTrials.gov