Status:
TERMINATED
Re-expression of ER in Triple Negative Breast Cancers
Lead Sponsor:
Emory University
Collaborating Sponsors:
Novartis
Eisai Inc.
Conditions:
Breast Cancer
Breast Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
Patients are being asked to take part in this study because they have metastatic breast cancer that is triple negative (does not express estrogen receptor (ER), progesterone receptor (PR) or HER2). Th...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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)
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01194908
Start Date
July 1 2010
End Date
January 1 2014
Last Update
January 26 2015
Active Locations (1)
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1
Emory University Winship Cancer Institute
Atlanta, Georgia, United States, 30329