Phase I/II Trial of Ruxolitinib in Combination with Trastuzumab in Metastatic HER2 Positive Breast Cancer

Protocol: 
AAAM1906
Phase: 
I/II

Phase I/II Trial of Ruxolitinib in Combination with Trastuzumab in Metastatic HER2 Positive Breast Cancer

Ruxolitinib (Jakafi) is being used in an investigational manner in this research study. This means that Ruxolitinib has been approved by the Food and Drug Administration (FDA) for use in myelofibrosis, but it has not been approved for use in breast cancer. 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. 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. Trastuzumab (Herceptin) is an FDA-approved treatment for HER2 positive breast cancer. If you decide to participate in this study, you will 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.

Are you Eligible? (Inclusion Criteria)

To be eligible for this trial, patients must:
- have locally recurrent or metastatic breast cancer
- have cancer that progressed on at least two lines of HER2-directed
thereapy
- have had prior therapy with both pertuzumab and ado-trastuzumab
- be over 18 years of age
- have the ability to swallow, retain and absorb oral medication
Women and men of all races and ethnic groups are eligible for this trial.

Specialty Area(s)

Trial Location

Herbert Irving Comprehensive Cancer Center
161 Fort Washington Ave.
Herbert Irving Pavilion
New York, NY 10032
United States