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) ]

The number of premalignant breast cells in apoptosis at the time of diagnosis will be compared to the number of cells in apoptosis following treatment with 15 (+/- 5) days of ruxolitinib or placebo.


Original Primary Outcome: Change in Apoptosis [ Time Frame: 15 days (+/- 5 days) ]

The number of premalignant breast cells in apoptosis at the time of diagnosis will be compared to the number of cells in apoptosis following treatment with 15 (+/- 5) days of ruxolinitib or placebo.


Current Secondary Outcome: pSTAT5 [ Time Frame: 15 days (+/- 5 days) ]

To determine the difference in change in pSTAT5 levels between diagnosis and surgery as a function of ruxolitinib treatment versus placebo


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