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Old 02-19-2015, 02:09 PM   #1
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Join Date: Feb 2015
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Phase I/II Trial of Ruxolitinib with Trastuzumab in Metastatic HER2+ Breast Cancer

Columbia University Medical Center is currently enrolling in a research study entitled “Phase I/II Trial of Ruxolitinib in Combination with Trastuzumab in Metastatic HER2 Positive Breast Cancer”

The purpose of this study is to determine whether the combination of Ruxolitinib plus Trastuzumab is safe and effective in stopping breast tumor growth in patients with HER2 positive metastatic breast tumors who have already received Trastuzumab. Ruxolitinib is a targeted therapy that inhibits the JAK/STAT growth pathway. Based upon pre-clinical laboratory data, the JAK/STAT pathway is important for HER2 positive breast cancers to grow. Ruxolitinib (Jakafi) is an Food and Drug Administration (FDA) approved treatment for myelofibrosis (a disease of the bone marrow), but its safety and clinical efficacy in breast cancer patients is not known.

Those who enroll to the study receive oral Ruxolitinib every day in combination with intravenous Trastuzumab every 3 weeks. The first 10 patients will participate in the phase I portion of the trial, in which different doses of Ruxolitinib will be evaluated in order to determine the appropriate and safe dose in combination with Trastuzumab. The dose of Trastuzumab is known and not investigational. All subsequent patients will be enrolled in the phase II part of the trial, in which the appropriate dose (as
determined by phase I) will be evaluated in combination with Trastuzumab. The goal of the phase II portion will be to determine if there is an improvement in stopping breast cancer growth in patients receiving the combination of Ruxolitinib plus Trastuzumab. Additional information can be found at https://clinicaltrials.gov/ct2/show/...+breast&rank=1

If you are interested in learning more about this trial, please contact the principal investigator, Dr. Kevin Kalinsky at 212-305-1945 of kk2693@cumc.columbia.edu
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