A Study of Herceptin (Trastuzumab) in Women With Metastatic Breast Cancer
Status:
Completed
Trial end date:
2012-06-01
Target enrollment:
Participant gender:
Summary
This 2 arm study will assess the efficacy and safety of intravenous Herceptin with or without
a taxane for the first line treatment of metastatic breast cancer in women who have relapsed
at least 12 months after a minimum of 10 months of (neo)adjuvant treatment with Herceptin for
HER2-positive early breast cancer.Patients will receive either Herceptin monotherapy (loading
dose of 4mg/kg iv, followed by weekly doses of 2mg/kg iv, or 8mg/kg loading dose followed by
3-weekly doses of 6mg/kg)or Herceptin + a taxane (docetaxel 100mg/m2 iv every 3 weeks, or
paclitaxel 175mg/m2 iv every 3 weeks or 75mg/m2 every week). The anticipated time on study
treatment is until disease progression, and the target sample size is <100 individuals.