At a glance
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'A Study of the Effect of First Line Treatment With Paclitaxel and Myocet in Combination With Herceptin on Overall Tumor Response in Patients With Metastatic or Locally Advanced Breast Cancer and HER2 Overexpression.'
In Brief
A Phase 2 clinical trial evaluating trastuzumab, paclitaxel, and 1 other intervention for Breast Cancer. Completed, enrolled 69 participants across 1 site.
Detailed Summary
This study will define an optimal chemotherapy dose regimen of Myocet in combination with paclitaxel and intravenous Herceptin and will evaluate the efficacy and safety of this dose regimen in patients with metastatic or locally advanced breast cancer and HER2 overexpression. The anticipated time on study treatment is 3-12 months.
Study Details
Timeline
Interventions
Initial loading does of 4 mg/kg IV, followed by 2 mg/kg IV weekly, until disease progression
60 mg/m\^2 IV weekly; dose increased to 70 mg/m\^2, and subsequently 80 mg/m\^2, after 2 treatment cycles with no evidence of DLT until disease progression
40 mg/m\^2 IV weekly; dose increased to 50 mg/m\^2 IV after 2 treatment cycles with no evidence of DLT for 6 cycles