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Phase II Study of Ruxolitinib (INCB018424) in Patients With PSTAT3+ Breast Cancer

Phase 2
18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

Phase II Study of Ruxolitinib (INCB018424) in Patients With PSTAT3+ Breast Cancer

Tumor tissue will be tested for the presence of the pStat3 marker. Patients with a positive
test will be potentially eligible for study treatment (ruxolitinib). Patients with a
negative test will not be eligible to join the treatment portion of the study.

Participants with breast cancer that is accessible to a biopsy will undergo a research
biopsy procedure prior to beginning ruxolitinib. This biopsy is required as part of study
participation so research doctors can learn more about pSTAT3 as a marker for breast cancer.

Participatns will be given a drug-dosing calendar for each treatment cycle. Each treatment
cycle lasts 4 weeks, during which time the study drug will be taken by mouth twice a day
every day beginning on cycle 1 day 1.

During all cycles participants will undergo a physical exam, be asked questions about their
general health, be askd specific questions about any problems that they might be having and
any medications they may be taking.

Participants will also undergo blood tests, have tumor markers drawn, be asked to complete
health-realted questionnaires, and undergo body scans to assess the effects of ruxolitinib
on your tumor(s).

Partipant's medical condition will be followed for up to 2 years following study completion.
This will happen through medical record reviews as well as phone calls to the participant or
partipants' doctor.

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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective response by RECIST 1.1

Outcome Description:

Objective response by RECIST 1.1

Outcome Time Frame:

2 years

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

June 2012

Completion Date:

Related Keywords:

  • Breast Cancer
  • pSTAT3+
  • Breast Neoplasms



Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Brigham and Women's HospitalBoston, Massachusetts  02115
Massachusetts General HospitalBoston, Massachusetts  02114-2617