At a glance
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A Phase Ib/II, Open-label Study of the Safety, Tolerability, and Efficacy of Trastuzumab Emtansine (Trastuzumab-MCC-DM1, T-DM1) in Combination With Pertuzumab Administered Intravenously to Patients With Human Epidermal Growth Factor Receptor-2 (HER2)-Positive Locally Advanced or Metastatic Breast Cancer Who Have Previously Received Trastuzumab
In Brief
A Phase 2 clinical trial evaluating Trastuzumab emtansine [Kadcyla] 3.0 mg/kg, Trastuzumab emtansine [Kadcyla] 3.6 mg/kg, and 1 other intervention for Metastatic Breast Cancer. Completed, enrolled 67 participants across 20 sites in 7 countries.
Detailed Summary
This was a multi-institutional, multinational, open-label, single-arm Phase Ib/II study designed to evaluate the safety, tolerability, pharmacokinetics, and efficacy of trastuzumab emtansine (trastuzumab-MCC-DM1) administered by intravenous (IV) infusion in combination with pertuzumab in patients with human epidermal growth factor receptor-2 (HER2)-positive locally advanced or metastatic breast cancer who had previously received trastuzumab.
Study Details
Timeline
Interventions
Trastuzumab emtansine was provided as a single-use lyophilized formulation.
Trastuzumab emtansine was provided as a single-use lyophilized formulation.
Pertuzumab was provided as a single-use formulation.