Study on Ruxolitinib for Premalignant Breast Disease
Sponsor: Julie Nangia
ClinicalTrials ID:NCT02928978
This clinical trial is testing the effects of the drug ruxolitinib on early-stage breast cells that may become cancerous. Participants will either receive ruxolitinib or a placebo for about 15 days, followed by surgery to remove the affected breast tissue.
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Program Overview
The purpose of this study is to see how ruxolitinib, a medication, affects breast cells that are in a pre-cancerous state. Participants will be divided into two groups: one group will take ruxolitinib, and the other will take a placebo (a pill with no active drug) for around 15 days. After this period, all participants will have surgery to remove the pre-cancerous breast tissue.
Eligibility Criteria
Inclusion Criteria
- Have a breast biopsy showing certain types of pre-cancerous conditions like ADH, ALH, LCIS, or DCIS that need surgery.
- Tissue from the biopsy must be available for research.
- Men and women aged 18 and older.
- Have good blood and organ function, as shown by specific blood test results.
- Agree not to use certain medications that could interfere with ruxolitinib.
- Women and men must use effective birth control during the study.
- If genetic testing is done, results must be available before starting the study.
- Understand the study and agree to sign a consent form.
Exclusion Criteria
- Have used certain breast cancer prevention drugs within the past year.
- Have taken any experimental drugs within 30 days before the study.
- Have invasive breast cancer now or had it within the last 5 years.
- Have uncontrolled health issues like heart problems or severe infections.
- Are pregnant or breastfeeding.
- Are HIV-positive and on certain medications.
- Have used JAK inhibitors before.
- Have active Hepatitis B or C.
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