Ruxolitinib in Patients With Breast Cancer

Status: Recruiting
Phase: Phase 2
Diagnosis: Breast: Metastatic
NCT ID: NCT01562873 (View complete trial on
DFCI Protocol ID: 12-024


This research study is a Phase II clinical trial. Phase II trials test the effectiveness of an investigational drug to learn whether the drug works in treating a specific cancer. "Investigational" means that drug is still being studied and that research doctors are trying to find out more about it-such as the safest dose to use, the side effects it may cause, and if the drug is effective for treating different types of cancer. It also means that the FDA has not approved ruxolitinib for your type of cancer. 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.


Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital, Massachusetts General Hospital

Overall PI:
Nancy Lin, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:
Aditya Bardia MD, MPH, Massachusetts General Hospital

Dana-Farber Cancer Institute: Breast Cancer Nursing Team, 617-632-3478
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility 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
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