NCT00951665

A Study of Trastuzumab Emtansine, Paclitaxel, and Pertuzumab in Patients With HER2-Positive, Locally Advanced or Metastatic Breast Cancer

A Phase Ib-IIa, Open-label, Dose-Escalation Study of the Safety, Tolerability and Pharmacokinetics of Trastuzumab Emtansine, Paclitaxel and Pertuzumab Administered Intravenously to Patients With Her2-positive, Locally Advanced or Metastatic Breast Cancer

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 107 (actual)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This Phase Ib-IIa, multi-institutional, open-label, dose-escalation study is designed to evaluate the safety, tolerability, pharmacokinetics and feasibility of trastuzumab emtansine (T-DM1) administered by intravenous (IV) infusion in combination with paclitaxel (and pertuzumab, if applicable) in patients with human epidermal growth factor receptor 2-positive (HER2-positive), locally advanced or metastatic breast cancer.

Conditions

• Metastatic Breast Cancer

Interventions

Type	Name	Description
DRUG	paclitaxel	Intravenous repeating dose
DRUG	pertuzumab [Perjeta]	Intravenous repeating dose
DRUG	trastuzumab emtansine [Kadcyla]	Intravenous escalating dose
DRUG	paclitaxel	Intravenous escalating dose
DRUG	trastuzumab emtansine [Kadcyla]	Intravenous repeating dose

Timeline

• Start date: 2009-08-01
• Primary completion: 2012-02-01
• Completion: 2013-06-01
• First posted: 2009-08-04
• Last updated: 2016-06-24
• Results posted: 2016-06-24

Locations

5 sites across 1 country: United States