A Study of Kadcyla (Trastuzumab Emtansine) in Patients With HER2 Positive Breast Cancer Who Have Received Prior Anti-HER2 And Chemotherapy-based Treatment (NCT01702571)
This two-cohort, open-label, multicenter study will assess the safety and the efficacy of ado-trastuzumab emtansine (T-DM1, Kadcyla®; Genentech, Inc.) in patients with HER2-positive locally advanced or metastatic breast cancer who have received prior anti-HER2 and chemotherapy-based treatment. Patients in Cohort 1 will be drawn from the general patient population; Cohort 2 will include only asian patients. Patients in both cohorts will receive 3.6 mg/kg Kadcyla intravenously every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
This trial is sponsored by F. Hoffmann-La Roche. 
- Condition: Breast Cancer
- Phase: III
- Estimated Enrollment: 2220
- Start: November 2012
- Estimated Completion: July 2018
- Last verified: July 2015
Last Editorial review: July 30, 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.