This trial is active, not recruiting.

Condition breast cancer
Treatment myocet
Phase phase 3
Sponsor Sopherion Therapeutics
Start date January 2006
Trial size 363 participants
Trial identifier NCT00294996, STM01-102


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Progression-Free Survival
time frame:

Secondary Outcomes

Overall Survival
time frame:
time frame:

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title A Phase III Randomized, Controlled Trial of Myocet, Trastuzumab and Paclitaxel Versus Trastuzumab and Paclitaxel for First-Line Therapy of Metastatic Breast Cancer
Principal investigator Jose Baselga, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in March 2009.
Information provided to ClinicalTrials.gov by Sopherion Therapeutics.