Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Emory University
With
Novartis
Eisai Inc.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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)
You may not be if
Patients with an active infection or with a fever \> 101.30 F within 3 days of the first scheduled day of protocol treatment
Patients with active central nervous system (CNS) metastases. Patients with stable CNS disease, who have undergone radiotherapy at least 4 weeks prior to the planned first protocol treatment and who have been on a stable dose of corticosteroids for \>3 weeks are eligible for the trial
History of prior malignancy within the past 5 years except for curatively treated basal cell carcinoma of the skin, cervical intra-epithelial neoplasia, or localized prostate cancer with a current prostate-specific antigen (PSA) of \< 1.0 mg/dL on 2 successive evaluations, at least 3 months apart, with the most recent evaluation no more than 4 weeks prior to entry
Patients with known hypersensitivity to any of the components of decitabine or LBH589
Patients who received radiotherapy to more than 25% of their bone marrow; or patients who received any radiotherapy within 4 weeks of entry
Patients who are receiving concurrent investigational therapy or who have received investigational therapy within 28 days of the first scheduled day of protocol treatment (investigational therapy is defined as treatment for which there is currently no regulatory authority approved indication)
Peripheral neuropathy \>= Grade 2
Patients who are pregnant or lactating
Any other medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results.
History of allogeneic transplant
Known HIV or Hepatitis B or C (active, previously treated or both)
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