New EORTC TREAT CTC intergroup trial for patients with HER2 negative primary breast cancer

Early stage breast cancer is potentially curable, yet some patients still relapse even though they have had optimal treatment. It is thought that these patients relapse due to the presence of micro metastatic cells that cannot be detected by the imaging or conventional laboratory tests used following completion of the standard treatment. Recent studies have shown that the presence of circulating tumor cells (CTCs), either before or after a patient has received adjuvant chemotherapy, is a prognostic factor for poor clinical outcome in these patients.

The EORTC 90091-10093 Treat CTC trial, TRastuzumab in HER2-negative Early breast cancer as Adjuvant Treatment for Circulating Tumor Cells, plans to screen up to 2175 patients with HER2 (human epidermal growth factor receptor 2) negative early breast cancer who have completed (neo)adjuvant chemotherapy and surgery for CTCs in order to randomize 174 patients with CTCs. Treat CTC will investigate whether trastuzumab can reduce CTC detection (primary objective) and disease recurrences (secondary objective) compared to observation in women with HER2-negative early breast cancer.

Dr. Michail Ignatiadis of the Institut Jules Bordet, Université Libre de Bruxelles, Brussels, and Coordinator of this study says, “The European Treat CTC trial, together with the NSABP B-47 trial which is ongoing in the United States, will explore the role of trastuzumab in women with HER2-non amplified, early breast cancer. The EORTC Breast Cancer Group and our partners are very pleased to offer our patients the possibility of inclusion in this trial.”

TREAT CTC is an intergroup trial coordinated by the EORTC Breast Cancer Group in collaboration with SUCCESS in Germany and UNICANCER in France. This EORTC trial is run under the BIG (Breast International Group) umbrella and is supported by an educational grant from Roche, who also supplies Herceptin, the drug used in the study. Veridex supplies kits for the central testing of circulating tumor cells in blood samples used for screening patients to be entered in the trial.

EORTC trial 90091-10093 will open in 75 sites located in six countries: Belgium, France, Germany, the United Kingdom, Greece, and Austria.

For more information concerning EORTC trial 90091-10093 please contact: www.eortc.org/contact

John Bean, MA PhD
EORTC, Medical Science Writer