A Randomized Phase II Window-of-opportunity Trial of Ruxolitinib in Patients with High Risk and Premalignant Breast Conditions
C
Carla Fisher, MD
Primary Investigator
Overview
This study is being done in order to see how ruxolitinib changes the breast cell when administered to participants with premalignant breast conditions.
Description
Participants will first complete screening: tests/procedures considered standard treatment for premalignant breast disease, plus a research blood draw.
If eligible, participants will then be randomly assigned to receive either Ruxolitinib 20 mg, or placebo, twice daily for 10-20 days followed by surgery.
Participants will complete a pre-surgery visit, to include: blood test, review of medications, review of side effects.
Participants will return to the clinic about 2-4 weeks after surgery as part of routine care for premalignant breast condition. During this visit, participants will complete a physical exam, review of medications, and pill count to verify how many doses of the study medication were taken.
Eligibility
You may be eligible for this study if you meet the following criteria:
-
Conditions:
High Risk and Premalignant Breast Conditions
-
Age: Between 18 Years - 100 Years
-
Gender: All
Individuals at least 18 years of age with a breast biopsy showing atypical ductal hyperplasia (ADH), atypical lobular hyperplasia (ALH), lobular carcinoma in situ (LCIS), or ductal carcinoma in situ (DCIS), requiring surgical excision.
Individuals with current or previous history of invasive breast cancer, uncontrolled intercurrent illness, or HIV-positive on combination antiretroviral therapy will not be eligible.
Women who are pregnant or breastfeeding will not be eligible.
Updated on
23 Apr 2024.
Study ID: 1905869883
Please visit our main page to search for other studies you may be interested in.
If you need help finding a study or have any questions, please contact us at inhealth@iu.edu
