NCT00377780

Liposomal Doxorubicin, Trastuzumab, and Docetaxel in HER2 Positive Metastatic Breast Cancer

Phase II Multicentre Open Label Study Evaluating the Efficacy and Safety of Liposomal Doxorubicin, Trastuzumab, Docetaxel as First-line Treatment of Patients With HER2 Positive Metastatic Breast Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Laurence J.C. van Warmerdam · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open phase II study evaluating the efficacy and safety of the non pegylated liposomal doxorubicin (Myocet®), trastuzumab (Herceptin®), and docetaxel (Taxotere®) combination as first-line treatment of patients with metastatic HER2/neu positive 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 positive breast cancer not yet treated with chemotherapy for metastatic disease. Myocet and Taxotere will be given for a maximum of 6 cycles, Herceptin treatment for 1 year is recommended. 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, trastuzumab, docetaxel	max. 6 courses

Timeline

• Start date: 2006-08-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2006-09-18
• Last updated: 2015-09-23

Locations

7 sites across 1 country: Netherlands