Ruxolitinib for Premalignant Breast Disease

  • STATUS
    Recruiting
  • End date
    Jan 18, 2025
  • participants needed
    100
  • sponsor
    Julie Nangia
Updated on 18 February 2021
neutrophil count
carcinoma in situ
lobular carcinoma
lobular carcinoma in situ
clarithromycin
breast disease
ductal hyperplasia
atypical ductal hyperplasia
breast biopsy
antifungals

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.

Details
Condition Ductal Carcinoma In Situ, Adenocarcinoma, Ductal Carcinoma In Situ (DCIS), Atypical Ductal Hyperplasia, Atypical Lobular Hyperplasia, Lobular Carcinoma In Situ, Malignant Adenoma, LCIS, dcis
Treatment Ruxolitinib, Placebo (for Ruxolitinib)
Clinical Study IdentifierNCT02928978
SponsorJulie Nangia
Last Modified on18 February 2021

Eligibility

Yes No Not Sure

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 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

Exclusion Criteria

Treatment with selective estrogen receptor modulators (SERMs) or aromatase inhibitors for breast cancer prevention within 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
Treatment with any other investigational agents within 30 days of starting study treatment
Current diagnosis of invasive breast cancer (current microinvasive disease is allowed), or previous history of invasive breast cancer diagnosed within the last 5 years
NOTE: If previous history of ER+ invasive breast cancer diagnosed > 5 years
Prior or current treatment with a JAK inhibitor, for any indication
ago, patient must be off endocrine therapy for at least 1 year prior to
starting study treatment
Women who are pregnant or nursing
HIV-positive participants on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with ruxolitinib
Known active Hepatitis B or C
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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