April 12, 2011

Study Enrolling Women with HER2-positive, Advanced Breast Cancer


The Phase III EMILIA trial is enrolling women with previously treated, HER2-positive, locally advanced or metastatic breast cancer. The study is evaluating an investigational drug known as trastuzumab emtansine (T-DM1). T-DM1 links the HER2-targeted drug Herceptin® (trastuzumab) with a chemotherapy drug (DM1). T-DM1 delivers Herceptin and DM1 directly to HER2-positive cells.

Approximately 20-25% of breast cancers overexpress (make too much of) the HER2 protein. HER2-targeted therapies such as Herceptin have dramatically improved outcomes for women with HER2-positive breast cancer, but researchers continue to explore new approaches to treatment. One important focus of research is the treatment of cancer that has progressed (worsened) after prior HER2-targeted therapy.

T-DM1 produced promising results in a Phase II clinical trial of women who had received several prior treatments for HER2-positive breast cancer: 26% of women experienced tumor shrinkage.1 The EMILIA trial builds on these findings by enrolling a larger number of women and comparing T-DM1 with a standard treatment approach. The study is limited to women who have received prior treatment for HER2-positive breast cancer that includes a taxane and Herceptin. Study participants are assigned to treatment with either T-DM1 or Xeloda® (capecitabine) plus Tykerb® (lapatinib). Xeloda and Tykerb are approved for the treatment of metastatic breast cancer; there is no placebo group in this study.

The study is being conducted at 107 sites in 37 states. As of April 2011, close to 700 of a total of 980 women have been enrolled. Complete information about eligibility criteria is available at www.emiliaclinicaltrial.com. Women who are considering a clinical trial are advised to discuss the risks and benefits with their physician.


1 Burris HA, Rugo HS, Vukelja SJ et al. Phase II study of the antibody drug conjugate trastuzumab-DM1 for the treatment of human epidermal growth factor receptor 2 (HER2) – positive breast cancer after prior HER2-directed therapy. Journal of Clinical Oncology. 2011;29:398-405.

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