Re-expression of ER in Triple Negative Breast Cancers

Inclusion Criteria

• •Histologically or cytologically confirmed triple negative (ER-, PR-, HER2-) metastatic or locally advanced breast cancer
• •Measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
• •Disease that is assessable to biopsy for hormone receptor measurement
• •At least one line of therapy prior to study entry (acceptable therapies include chemotherapy ± anti-angiogenic therapy). Other investigational therapies except DNA methyltransferase (DNMT) and histone deacetylase (HDAC) inhibitors are allowed.
• •Age \> 18 years
• •Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1 (Appendix A)
• •Adequate bone marrow as evidenced by:
• •* Absolute neutrophil count \> 1,500/μL
• •* Platelet count \> 100,000/μL
• •Adequate renal function as evidenced by serum creatinine \< 1.5 mg/dL
• •Adequate hepatic function as evidenced by:
• •* Serum total bilirubin \< 1.5 mg/dL
• •* Alkaline phosphatase \< 3 times the upper limit of normal (ULN) for the reference lab (\< 5 times the ULN for patients with known hepatic metastases
• •* Serum glutamic-oxaloacetic transaminase (SGOT)/serum glutamic-pyruvic transaminase (SGPT) \< 3 times the ULN for the reference lab (\< 5 times the ULN for patients with known hepatic metastases
• •Patients must be recovered from both the acute and late effects of any prior surgery, radiotherapy or other antineoplastic therapy
• •Patients or their legal representatives must be able to read, understand and provide informed consent to participate in the trial.
• •Consent to biopsy before and after therapy with decitabine and LBH589.
• •Patients of childbearing potential and their partners must agree to use an effective form of contraception during the study and for 90 days following the last dose of study medication (an effective form of contraception is an oral contraceptive or a double barrier method)