Ruxolitinib for Premalignant Breast Disease (NCT02928978) | Clinical Trial Compass
CompletedPhase 2
Ruxolitinib for Premalignant Breast Disease
United States84 participantsStarted 2018-05-13
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Have a breast biopsy showing ADH (atypical ductal hyperplasia), ALH (atypical lobular hyperplasia), LCIS (lobular carcinoma in situ), or DCIS (ductal carcinoma in situ) requiring surgical excision. Microinvasive disease is allowed.
* NOTE: Tissue from the diagnostic biopsy must be accessible/available for research correlates (i.e., a tissue block or \~10 unstained slides). Due to the nature of the study, fewer slides may be accepted with prior permission from the Protocol Chair if there is insufficient tissue.
* Women and men age 18 and older.
* Adequate hematologic and organ function, defined as follows:
* Absolute neutrophil count ≥ 1500/mm3
* Hemoglobin ≥ 9.0 g/dL
* Platelet levels \>200 x 109/L
* Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN)
* AST/ALT ≤ 2.5 x institutional ULN
* Alkaline phosphatase ≤ 5 x institutional ULN
* Creatinine clearance \> 50 mL/min as calculated by the Cockcroft-Gault method
* Willing to not use concomitant strong CYP3A4 inhibitors as this could interfere with the metabolism of ruxolitinib (i.e azole antifungals, clarithromycin, conivaptan, grapefruit juice, mibefradil, nefazodone, protease inhibitors, telithromycin).
* Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.
* If the patient undergoes germline genetic testing, the results…