Clinical Trial: Ruxolitinib for Premalignant Breast Disease
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: TBCRC 042 - A Randomized Phase II Window-of-Opportunity Trial of Ruxolitinib in Patients With High Risk and Premalignant Breast Conditions
Brief Summary: This 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.
Detailed Summary:
Sponsor: Julie Nangia
Current Primary Outcome: Change in Apoptosis [ Time Frame: 15 days (+/- 5 days) ]
Original Primary Outcome: Change in Apoptosis [ Time Frame: 15 days (+/- 5 days) ]
Current Secondary Outcome: pSTAT5 [ Time Frame: 15 days (+/- 5 days) ]
Original Secondary Outcome: Same as current
Information By: Baylor Breast Care Center
Dates:
Date Received: October 7, 2016
Date Started: January 2017
Date Completion: January 2020
Last Updated: February 7, 2017
Last Verified: February 2017