An Observational Study of Kadcyla Safety in Breast Cancer (NCT02305641)
This is a phase IV, prospective, multicenter, non-interventional study (regulatory post-marketing surveillance) in approximately 3,000 patients who are to receive ado-trastuzumab emtansine (T-DM1, Kadcyla®; Genentech, Inc.). Patients with HER2-positive, unresectable locally advanced or metastatic breast cancer, who have received prior treatment with trastuzumab and a taxane, and administered Kadcyla infusion at physician’s discretion will be registered for this surveillance in Korea. Patients will be asked to provide informed consent; data will be collected by electronic Case Report Forms for approximately 6 years.
This trial is sponsored by F. Hoffmann-La Roche. 
- Condition: Breast Cancer
- Phase: N/A
- Estimated Enrollment: 3000
- Start: May 2015
- Estimated Completion: January 2020
- Last verified: July 2015
Last Editorial review: July 31, 2015
Information based on ClinicalTrials.gov (NIH/NCI) and other sources.
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