Ruxolitinib in Patients With Breast Cancer

• Status: Terminated
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Ruxolitinib is a drug which blocks the Janus tyrosine Kinase (JAK) signaling pathway. It is thought that this pathway might be important in certain types of breast cancer, and that blocking this pathway might lead to anti-cancer effects. This study is testing the effects of ruxolitinib in patients with breast cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed invasive breast cancer

• Must have known ER, PR and HER2 status

• Either, Triple Negative Metastatic Breast Cancer or

• Inflammatory Breast Cancer with any ER, PR HER2 status

• Availability of archival tissue specimen suitable for pStat3 testing

• Life expectancy of greater than 3 months

• Measurable disease by RECIST

• At least one prior chemotherapy regimen for treatment of metastatic breast cancer and/or recurrence within 12 months of completion of neoadjuvant/adjuvant chemotherapy or

• For patients with inflammatory breast cancer but no distant metastases, progression through standard neoadjuvant chemotherapy is required

Exclusion Criteria:

• Pregnant or breastfeeding

• Active brain metastases

• History of allergic reactions attributed to compounds of similar chemical or biologic composition to ruxolitinib

• Clinically significant malabsorption syndrome

• Concurrent use of medications/substances that are strong inhibitors of CY3A4

• No uncontrolled intercurrent illness