Trial | NCT00294996  Report issue

Title

Trial of Myocet in Metastatic Breast Cancer
A Phase III Randomized, Controlled Trial of Myocet, Trastuzumab and Paclitaxel Versus Trastuzumab and Paclitaxel for First-Line Therapy of Metastatic Breast Cancer

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    363
The purpose of the study is to examine the safety and effectiveness of the drug combination of Myocet, paclitaxel and trastuzumab compared to paclitaxel and trastuzumab without Myocet, as first line treatment for patients with metastatic HER2+ breast cancer.
Study Started
Jan 31
2006
Last Update
Mar 31
2009
Estimate

Drug Myocet

Criteria 

Inclusion Criteria:

Metastatic Her2+ Breast cancer by FISH analysis
No prior chemotherapy for metastatic disease
Measurable disease
normal left ventricular ejection fraction

Exclusion Criteria:

prior doxorubicin treatment exceeding 300 mg/m2 or epirubicin exceeding 600 mg/m2
relapse within 12 months of completion of adjuvant trastuzumab, taxane or anthracycline therapy
No Results Posted