Bayer 17096, A Phase II Randomized, Double-blind, Placebo-controlled Trial of Radium-223 Dichloride in Combination With Exemestane and Everolimus Versus Placebo in Combination With Exemestane and Everolimus When Administered to Metastatic Her2 Negative Hormone Receptor Positive Breast Cancer Subjects With Bone Metastases
Cancer - Breast
Principal Investigator: Randa Loutfi, MD
The purpose of this study is to assess efficacy and safety of radium 223 dichloride in subjects with human epidermal growth factor receptor 2 (HER2) negative hormone receptor positive breast cancer with bone metastases treated with exemestane and everolimus.
Women more than 18 years of age with metastatic breast cancer not amenable to curative treatment by surgery or radiotherapy; confirmation of estrogen receptor positive (ER+) and HER2 negative adenocarcinoma of the breast; bone dominant disease with at least 2 skeletal metastases at baseline; must have received at least one line of hormonal therapy in the metastatic setting.