drugset / Trial / NCT01194908

Re-expression of ER in Triple Negative Breast Cancers

NCT01194908

NaSingle-groupOpen-labelTreatment

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). This means that agents such as trastuzumab (Herceptin®) and tamoxifen are not currently treatment options for their cancer. Another option for treating the patient's cancer at this point is with chemotherapy. The patient should discuss this and other options with their doctor prior to entering this study. Laboratory studies have demonstrated that ER is actually present in some triple negative breast cancers but is "silenced" (does not function properly) because methyl and histone groups are attached to it and inactivate it. Special drugs called demethylating inhibitors (such as decitabine) and histone deacetylase inhibitors (such as LBH589) can remove these methyl and histone groups and reactivate ER. This reactivated ER can then be targeted with agents like tamoxifen. The patient is being asked to join this clinical research study to find out if ER can be reactivated in their cancer using decitabine in combination with LBH589. If ER is reactivated in their cancer, we will then determine if tamoxifen can decrease the growth of the cancer.

Timeline

Start
2010-07
Primary completion
2014-01
Completion
2014-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Decitabine Small molecule 5 mg/m2 Intravenous
Subject Decitabine Small molecule 10 mg/m2 Intravenous
Subject Decitabine Small molecule 15 mg/m2 Intravenous
Subject Decitabine Small molecule 20 mg/m2 Intravenous
Subject Panobinostat Small molecule 10 mg/m2 Intravenous
Subject Panobinostat Small molecule 15 mg/m2 Intravenous
Subject Panobinostat Small molecule 20 mg/m2 Intravenous
Subject Tamoxifen Small molecule

Indications