NCT00193037

Doxorubicin HCI Liposome Injection Versus Weekly Docetaxel in Patients First Relapse Metastatic Breast Cancer

A Phase II Randomized Crossover Study Doxorubicin HCI Liposome Injection Versus Weekly Docetaxel in Patients First Relapse Metastatic Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: SCRI Development Innovations, LLC · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Upon determination of eligibility, patients will be randomly assigned to one of two treatment arms: * Liposomal Doxorubicin * Docetaxel For ever 2 patients treated, 1 will receive treatment A (Liposomal Doxorubicin) and 1 will receive treatment B (Docetaxel). Patients demonstrating progression on either ARM will be eligible for cross over to treatment in the other ARM, provided patient still meets the eligibility laboratory and performance status criteria. The study is not blinded so both the patient and the doctor will know which treatment has been assigned.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Liposomal Doxorubicin	Liposomal Doxorubicin
DRUG	Docetaxel	Docetaxel

Timeline

• Start date: 2001-02-01
• Primary completion: 2008-12-01
• Completion: 2009-11-01
• First posted: 2005-09-19
• Last updated: 2013-07-31
• Results posted: 2013-07-19

Locations

1 site across 1 country: United States