CRAD001J 2301: A Randomized Phase III, Double-Blind, Placebo-Controlled Multicenter Trial of Everolimus in Combination with Trastuzumab and Paclitaxel, as First Line Therapy in Women with HER2 Positive Locally Advanced or Metastatic Breast Cancer

Summary:
This study will compare progression free survival (length of time after treatment in which cancer does not get worse) between combination treatment of everolimus or placebo with trastuzumab and paclitaxel in patients with HER2-overexpressing (over expression of this protein causes rapid cell and tumor growth), unresectable (cannot be surgically removed) locally advanced or metastatic breast cancer.

Eligibility and Treatment Plan:

1. Histologically or cytologically confirmed invasive breast carcinoma with local recurrence or radiological evidence of metastatic disease.
2. HER2+ patients by local laboratory testing (IHC 3+ staining or in situ hybridization positive)
3. At least 18 years of age

Please call the Continuum Cancer Research Program: 212-844-6286 for more information.