A Study of Trastuzumab-MCC-DM1 Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer Who Have Previously Received a Trastuzumab-Containing Regimen

Phase 1 Completed 54 enrolled Genentech, Inc.

Non-randomizedSingle-groupOpen-labelTreatment

Summary

This is a phase I, multicenter, open-label, dose-escalation study of single-agent trastuzumab-MCC-DM1 administered by intravenous (IV) infusion in patients with HER2-positive metastatic breast cancer (MBC) who have previously received trastuzumab. The study will assess the safety, tolerability, and pharmacokinetics of trastuzumab-MCC-DM1 and determine the dose and schedule to be used in Phase II.

Timeline

Start: 2006-04
Primary completion: 2009-06
Completion: 2009-06

Publications

Beeram M, Krop IE, Burris HA, Girish SR, Yu W, Lu MW, Holden SN, Modi S. A phase 1 study of weekly dosing of trastuzumab emtansine (T-DM1) in patients with advanced human epidermal growth factor 2-positive breast cancer. Cancer. 2012 Dec 1;118(23):5733-40. doi: 10.1002/cncr.27622. Epub 2012 May 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Trastuzumab emtansine	Other / unclassified	1.2 mg/kg	Intravenous
Subject	Trastuzumab emtansine	Other / unclassified	2.4 mg/kg	Intravenous

A Study of Trastuzumab-MCC-DM1 Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer Who Have Previously Received a Trastuzumab-Containing Regimen

Summary

Timeline

Publications

Drugs

Indications