NCT00377559

Liposomal Doxorubicin and Docetaxel in HER2 Negative Metastatic Breast Cancer

Phase II Multicentre Open Label Trial Evaluating the Efficacy and Safety of the Liposomal Doxorubicin (Myocet®) and Docetaxel (Taxotere®) Combination as First-line Treatment of Patients With Metastatic HER2/Neu Negative Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Catharina Ziekenhuis Eindhoven · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open phase II multicentre study evaluating the efficacy and safety of the non pegylated liposomal doxorubicin (Myocet®) and docetaxel (Taxotere®) combination as first-line treatment of patients with metastatic HER2/neu negative breast cancer.

Detailed description

Phase II non comparative study, assessing the safety (primarily cardiac safety) and efficacy in patients with locally advanced or metastatic HER2/neu negative breast cancer not yet treated with chemotherapy for metastatic disease. Myocet and Taxotere will be given for a maximum of 6 cycles. Endpoints: cardiotoxicity (left ventricular ejection fraction decrease and/or symptoms of heart failure), serious other toxicity, disease progression.

Conditions

• Breast Cancer
• Neoplasm Metastasis

Interventions

Type	Name	Description
DRUG	Non pegylated liposomal doxorubicin and docetaxel	max. 6 courses

Timeline

• Start date: 2006-05-01
• Primary completion: 2009-11-01
• Completion: 2011-07-01
• First posted: 2006-09-18
• Last updated: 2015-10-06

Locations

10 sites across 1 country: Netherlands