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Trial Summary

Protocol No.TBCRC042
Principal InvestigatorFisher, Carla
PhasePhase II
Age GroupAdult
TitleA Randomized Phase II Window-of-opportunity Trial of Ruxolitinib in Patients with High Risk and Premalignant Breast Conditions
DescriptionThis study is evaluating how ruxolitinib affects premalignant breast cells. One half of the study participants will receive ruxolitinib for approximately 15 days, and the other half will receive a placebo (sugar pill) for approximately 15 days. Once study participants have completed their ruxolitinib or placebo, participants will undergo surgery to remove the premalignant breast tissue.
Key EligibilityIn order to be eligible to take part in this trial, patients must meet the following criteria:
  • Women and men age 18 and older.
  • Women of child bearing potential must have a negative pregnancy test prior to starting therapy. The effects of ruxolitinib on the developing human fetus are unknown. For this reason and because class C agents are potentially teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.
For a full list of participation criteria, please visit
Applicable Disease SitesBreast
Participating InstitutionsIndiana University (IU)
    Treatment TypePrevention
    ContactPhone: (317) 278-5632