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Trial record 1 of 1 for:    NCT02928978
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Ruxolitinib for Premalignant Breast Disease (TBCRC042)

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ClinicalTrials.gov Identifier: NCT02928978
Recruitment Status : Recruiting
First Posted : October 10, 2016
Last Update Posted : May 12, 2022
Incyte Corporation
Translational Breast Cancer Research Consortium
Information provided by (Responsible Party):
Julie Nangia, Baylor Breast Care Center

Brief 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.

Condition or disease Intervention/treatment Phase
Ductal Carcinoma In Situ Atypical Lobular Hyperplasia Atypical Ductal Hyperplasia Lobular Carcinoma In Situ Drug: Ruxolitinib Drug: Placebo (for Ruxolitinib) Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: TBCRC 042 - A Randomized Phase II Window-of-Opportunity Trial of Ruxolitinib in Patients With High Risk and Premalignant Breast Conditions
Actual Study Start Date : May 13, 2018
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : January 2025

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Ruxolitinib
Participants will receive ruxolitinib 20 mg by mouth twice daily for 15 days (+/- 5 days). Ruxolitinib will be supplied as four, 5 mg tablets.
Drug: Ruxolitinib
tablet (taken by mouth)
Other Names:
  • Jakafi
  • INCB018424

Placebo Comparator: Placebo
Participants will receive a placebo (sugar pill) that is designed to mimic ruxolitinib. The placebo will be supplied as four, 5 mg tablets. Participants assigned to this arm will take four, 5 mg tablets by mouth twice daily for 15 days (+/- 5 days).
Drug: Placebo (for Ruxolitinib)
tablet (taken by mouth)

Primary Outcome Measures :
  1. Change in Apoptosis [ Time Frame: 15 days (+/- 5 days) ]
    The number of premalignant breast cells in apoptosis at the time of diagnosis will be compared to the number of cells in apoptosis following treatment with 15 (+/- 5) days of ruxolitinib or placebo.

Secondary Outcome Measures :
  1. pSTAT5 [ Time Frame: 15 days (+/- 5 days) ]
    To determine the difference in change in pSTAT5 levels between diagnosis and surgery as a function of ruxolitinib treatment versus placebo

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  • 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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02928978

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Contact: Kristen Otte 713-798-8874 clinical-research@breastcenter.tmc.edu

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United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: Shelley Hill    205-934-4173    shill26@uab.edu   
Principal Investigator: Catherine Parker, MD         
United States, Indiana
Indiana University Melvin and Bren Simon Cancer Center Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Versie Barnes    317-278-3127    barnesv@iu.edu   
Principal Investigator: Carla Fisher, MD         
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10461
Contact: Anton Lulaj    718-405-8539    alulaj@montefiore.org   
Principal Investigator: Sheldon Feldman, MD         
United States, North Carolina
University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Crissey Tait    984-974-8675    crissey_tait@med.unc.edu   
Principal Investigator: Kristalyn Gallagher, DO         
United States, Tennessee
Vanderbilt-Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Clinical Trials Information Program    800-811-8480      
Principal Investigator: Ingrid Meszoely, MD         
United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Claudette Foreman    713-798-7315    cforema@bcm.edu   
Principal Investigator: Julie Nangia, M.D.         
Sub-Investigator: Mothaffar Rimawi, M.D.         
Sub-Investigator: Bora Lim, M.D.         
Sub-Investigator: C. Kent Osborne, M.D.         
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Diane Weber, RN    346-212-1287    dweber@mdanderson.org   
Principal Investigator: Parijatham Thomas, MD         
Sponsors and Collaborators
Julie Nangia
Incyte Corporation
Translational Breast Cancer Research Consortium
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Principal Investigator: Julie Nangia, M.D. Baylor College of Medicine
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Responsible Party: Julie Nangia, Assistant Professor, Baylor Breast Care Center
ClinicalTrials.gov Identifier: NCT02928978    
Other Study ID Numbers: H-38855
First Posted: October 10, 2016    Key Record Dates
Last Update Posted: May 12, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Julie Nangia, Baylor Breast Care Center:
Premalignant Breast Disease
Breast Cancer Prevention
Additional relevant MeSH terms:
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Carcinoma in Situ
Carcinoma, Ductal
Carcinoma, Intraductal, Noninfiltrating
Precancerous Conditions
Carcinoma, Lobular
Breast Carcinoma In Situ
Breast Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Pathologic Processes
Neoplasms, Ductal, Lobular, and Medullary
Skin Diseases
Breast Neoplasms
Neoplasms by Site