Corrected QT Interval Effects of Trastuzumab Emtansine (T-DM1) in Patients With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Locally Advanced or Metastatic Breast Cancer and the Safety and Tolerability of Combined T-DM1 and Pertuzumab in Patients With Early Disease Progression (NCT00943670)
This is a multicenter, open-label, single-arm Phase II study designed to evaluate the effect of Trastuzumab Emtansine (T-DM1, Kadcyla®; Genentech, Inc.) on the duration of corrected QT (QTc) interval in patients with HER2-positive locally advanced or metastatic breast cancer and to make preliminary assessments regarding the safety, tolerability, and efficacy of combined T-DM1 and Pertuzumab (Perjeta®; Genentech, Inc.) in patients with early disease progression.
The QT interval is a measure of time between the start of the Q wave and the end of the T wave in the heart’s electrical cycle. The QTcF interval is the QT interval as calculated using Fridericia’s correction; the QTcB interval is the QT interval as calculated using Bazett’s correction.
This trial is sponsored by Genentech. 
- Condition: Metastatic Breast Cancer
- Phase: II
- Enrollment: 51
- Study Start Date: July 2009
- Study Completion Date: August 2011
- Last verified: May 2013
Last Editorial review: July 27, 2015
Information based on ClinicalTrials.gov (NIH/NCI) and other sources.
Copyright © 2015 InPress Media Group. All rights reserved. Republication or redistribution of InPress Media Group content, including by framing or similar means, is expressly prohibited without the prior written consent of InPress Media Group. InPress Media Group shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon. ADC Review / Journal of Antibody-drug Conjugates is a registered trademarks and trademarks of InPress Media Group around the world.