Bayer 16298, A Phase II Randomized, Double-blind, Pacebo-controlled Trial of Radium-223 Dichloride Versus Placebo When Administered to Metastatic HER2 Negative Hormone Receptor Positive Breast Cancer Subjects With Bone Metastases Treated With Hormonal Treatment Background Therapy
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 negative (HER2 negative)hormone receptor positive breast cancer with bone metastases treated with hormonal treatment background therapy.
Confirmation of estrogen receptor positive (ER+) and HER2 negative adenocarcinoma of the breast; women 18 years of age or older with breast cancer not amenable to curative treatment by surgery or radiotherapy; bone dominant disease with at least 2 skeletal metastases identified at baseline; must have received at least one line of hormonal therapy in the metastatic setting.