- 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 must be received prior
to randomization, as the results may affect the surgical approach and, in turn, the
date of surgical excision.
- Patient understands the study regimen, its requirements, risks, and discomforts, and
is able and willing to sign a written informed consent document.
- Treatment with selective estrogen receptor modulators (SERMs) or aromatase inhibitors
for breast cancer prevention within 1 year prior to starting study treatment.
- Treatment with any other investigational agents within 30 days of starting study
- Current diagnosis of invasive breast cancer (current microinvasive disease is
allowed), or previous history of invasive breast cancer diagnosed within the last 5
NOTE: If previous history of ER+ invasive breast cancer diagnosed > 5 years ago, patient
must be off endocrine therapy for at least 1 year prior to starting study treatment.
- Uncontrolled intercurrent illness including, but not limited to ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, end stage renal disease (ESRD), or psychiatric illness/social situations
that would limit compliance with study requirements.
- Women who are pregnant or nursing.
- HIV-positive participants on combination antiretroviral therapy are ineligible because
of the potential for pharmacokinetic interactions with ruxolitinib.
- Prior or current treatment with a JAK inhibitor, for any indication.
- Known active Hepatitis B or C.