A Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine Versus the Combination of Trastuzumab Plus Docetaxel in Patients With HER2-positive Breast Cancer (NCT02144012)
This is a Phase III, randomized, multicenter, multinational, two-arm, open-label clinical trial to investigate a first-line treatment of patients with HER2-positive metastatic breast cancer. The study will enroll patients with HER2-positive, unresectable, locally advanced breast cancer (BC) if they have recurrent disease or progressive disease (PD) despite primary multimodality therapy, and/or metastatic BC if they have not received prior chemotherapy for their metastatic disease. Eligible patients at up to approximately 40 sites in the Asia-Pacific region will be randomized in a 2:1 ratio to receive ado-trastuzumab emtansine (T-DM1, Kadcyla®; Genentech, Inc.) (Arm A) and will receive trastuzumab (Herceptin®;Genentech, Inc.) plus docetaxel (Docefrez®; Sun Pharmaceutical Industries Ltd.) (Arm B). All study drugs will be administered at in-clinic visits occurring every three weeks during the treatment phase. Trastuzumab plus docetaxel was chosen as the comparator in the control group (Arm B), as it represents a common first-line treatment option used in this patient population in China and other Asia-Pacific countries.
This trial is sponsored by F. Hoffmann-La Roche. 
- Condition: Metastatic Breast Cancer
- Phase: III
- Enrollment: 49
- Start: July 2014
- Estimated Completion: December 2019
- Last verified: June 2015
Last Editorial review: July 31, 2015
Information based on ClinicalTrials.gov (NIH/NCI) and other sources.
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