A Study of Trastuzumab Emtansine (T-DM1) in Combination With Docetaxel, and Potentially Pertuzumab, in Patients With Advanced Breast Cancer (NCT00934856)
This open-label, multi-center study will assess the safety and tolerability of adding ado- trastuzumab emtansine (Kadcyla®; Genentech, Inc.) (T-DM1) to docetaxel (Docefrez®; Sun Pharmaceutical Industries Ltd.) in patients with locally advanced or metastatic HER2-positive breast cancer. Patients will receive T-DM1 and docetaxel on Day 1 of each 3-week cycle. For patients with locally advanced breast cancer, pertuzumab (Perjeta®; Genentech, Inc.) may be added to trastuzumab emtansine and docetaxel. Anticipated time on study treatment is up to 6 cycles for patients with locally advanced breast cancer, until disease progression or unacceptable toxicity occurs for patients with metastatic breast cancer.
This trial is sponsored by F. Hoffmann-La Roche. 
- Condition: Breast Cancer
- Phase: I
- Enrollment: 99
- Start: July 2009
- Completion: October 2013
- Last verified: July 2015
Last Editorial review: July 30, 2015
Information based on ClinicalTrials.gov (NIH/NCI) and other sources.
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