Denosumab for Breast Cancer With Bone Mets

Inclusion Criteria

• •1. Patients have histological confirmation of breast carcinoma.
• •2. Patients have progressive metastatic disease with predominantly bone metastasis with 1 or more lesions and at least 1 bone lesion has pathological confirmation, have not been treated or have been treated with any prior therapies (including bisphosphonate treatment and/or radiation therapy). Patients can have soft tissue involvement (Lymph node and skin) and/or metastatic lesions at major organ sites (i.e. lung, liver, etc).
• •3. Patients have positive ER expression in the primary tumor site by IHC (defined as \>/=10%) (PR status is not required)
• •4. Adequate hematologic function: 1)Absolute neutrophil count (ANC) \>/= 1.0 x 10\^9/L, 2) Platelet count \>/= 50 x 10\^9/L, 3) Hemoglobin \>/= 9.0 g/dL
• •5. Adequate cardiac function (LVEF \>/= 45%) if patient has known cardiac dysfunction history
• •6. Adequate Renal function: Calculated creatinine clearance \>30 ml/min
• •7. Adequate Hepatic function: 1) Aspartate aminotransferase (AST) \</= 2.5 x ULN; 2) Alanine aminotransferase (ALT) \</= 2.5 x ULN; 3) Alkaline phosphatase (Alp) \</= 2.5 x ULN; 4) Total bilirubin \</= 2.0 x ULN
• •8. Serum calcium or albumin-adjusted serum calcium \>/=2.0mmol/L (8.0mg/dL) and \</= 2.9 mmol/L (11.5mg/dL)
• •9. Patients have ability and willingness to sign written informed consent.
• •10. Patients are 18 years of age or older.
• •11. Female patients of childbearing potential (A female not free from menses \> 2 years or not surgically sterilized) must be willing to use highly effective contraception to prevent pregnancy or agree to abstain from heterosexual activity throughout the study. Highly effective contraception, defined as male condom with spermicide, diaphragm with spermicide, intra-uterine device. Highly effective contraception must be used by both sexes during the study and must be continued for 5 months after the last dose of denosumab.
• •12. Female patients of childbearing potential must have negative serum pregnancy test \</= 21 days prior to starting study treatment.
• •13. Patients have CTC \>/=3.