Trial of Myocet in Metastatic Breast Cancer

Sopherion Therapeutics

Status and phase: Unknown; Phase 3

Conditions: Breast Cancer

Treatments: Drug: Myocet

Study type: Interventional

Funder types: Industry

Identifiers

NCT00294996

STM01-102

Details and patient eligibility

About

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.

Enrollment: 363 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)