Ruxolitinib for Premalignant Breast Disease

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Julie Nangia
Study ID
NCT02928978
Phase
PHASE2
Status
Completed

Conditions

  • Atypical Ductal Hyperplasia
  • Atypical Lobular Hyperplasia
  • Ductal Carcinoma In Situ
  • Lobular Carcinoma In Situ

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
May 13, 2018
Status verified
Apr 2026
Primary completion
Aug 29, 2024
Completion
Sep 18, 2024

Study Design

Enrollment
84 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ruxolitinib
    Participants will receive ruxolitinib 20 mg by mouth twice daily for 15 days (+/- 5 days). Ruxolitinib will be supplied as four, 5 mg tablets.
  • Placebo Comparator: Placebo
    Participants will receive a placebo (sugar pill) that is designed to mimic ruxolitinib. The placebo will be supplied as four, 5 mg tablets. Participants assigned to this arm will take four, 5 mg tablets by mouth twice daily for 15 days (+/- 5 days).

Primary Outcome Measure

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

Locations (8)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294-
Indiana University Melvin and Bren Simon Cancer CenterIndianapolisIndiana46202-
Montefiore Medical CenterThe BronxNew York10461-
University of North Carolina at Chapel HillChapel HillNorth Carolina27599-
Vanderbilt-Ingram Cancer CenterNashvilleTennessee37232-
Harris Health System - Smith ClinicHoustonTexas77054-
O'Quinn Medical Tower - McNair Campus; Dan L Duncan Comprehensive Cancer CenterHoustonTexas77054-
University of Texas MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham· Birmingham, ALIndiana University Melvin and Bren Simon Cancer Center· Indianapolis, INMontefiore Medical Center· The Bronx, NYUniversity of North Carolina at Chapel Hill· Chapel Hill, NCVanderbilt-Ingram Cancer Center· Nashville, TNHarris Health System - Smith Clinic· Houston, TX

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