Neoadjuvant TDM1 With Lapatinib and Abraxane Compared With Trastuzumab With Lapatinib and Paclitaxel (TEAL) (NCT02073487)
The purpose of this study is to evaluate the Pathological Complete Response (pCR) of the breast when ado-trastuzumab emtansine (T-DM1, Kadcyla®; Genentech, Inc.) plus lapatinib (Tykerb®; Novartis Pharmacueticals Co. plus paclitaxel (Abraxane®; Celgene Corp.). is combined in newly diagnosed HER2 positive breast cancer.
This is a randomized, open label Phase II neo-adjuvant study comparing the efficacy of neoadjuvant Trastuzumab Emtansine (TDM1) plus lapatinib follow by Abraxane, versus trastuzumab (Herceptin®;Genentech, Inc.) plus Lapatinib follow by pacitaxel.
This trial is sponsored by The Methodist Hospital System. 
- Condition: Breast Cancer
- Phase: II
- Estimated Enrollment: 30
- Start: February 2014
- Estimated Completion: June 2016
- Last verified: February 2014
Last Editorial review: July 30, 2015
Information based on ClinicalTrials.gov (NIH/NCI) and other sources.
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