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Ruxolitinib for Premalignant Breast Disease (TBCRC 042)

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ClinicalTrials.gov Identifier: NCT02928978
Recruitment Status : Recruiting
First Posted : October 10, 2016
Last Update Posted : November 20, 2019
Sponsor:
Collaborators:
Incyte Corporation
Translational Breast Cancer Research Consortium
Information provided by (Responsible Party):
Julie Nangia, Baylor Breast Care Center

Tracking Information
First Submitted Date  ICMJE October 7, 2016
First Posted Date  ICMJE October 10, 2016
Last Update Posted Date November 20, 2019
Actual Study Start Date  ICMJE May 3, 2018
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 19, 2016)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 7, 2016)
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 ruxolinitib or placebo.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 7, 2016)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Ruxolitinib for Premalignant Breast Disease
Official Title  ICMJE TBCRC 042 - A Randomized Phase II Window-of-Opportunity Trial of Ruxolitinib in Patients With High Risk and Premalignant Breast Conditions
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Ductal Carcinoma In Situ
  • Atypical Lobular Hyperplasia
  • Atypical Ductal Hyperplasia
  • Lobular Carcinoma In Situ
Intervention  ICMJE
  • Drug: Ruxolitinib
    ruxolitinib tablet
    Other Names:
    • Jakafi
    • INCB018424 Phosphate
  • Drug: Placebo (for Ruxolitinib)
    placebo tablet
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Ruxolitinib
  • 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).
    Intervention: Drug: Placebo (for Ruxolitinib)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 7, 2016)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2025
Estimated Primary Completion Date January 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 must have a negative pregnancy test prior to starting therapy. The effects of ruxolitinib on the developing human fetus are unknown. For this reason and because class C agents are potentially teratogenic, 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.
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Participants may not be receiving any other investigational agents within 30 days of enrollment.
  • Participants with current or previous history of invasive breast cancer (current microinvasive disease is allowed).
  • 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.
  • Pregnant or nursing women are excluded from this study
  • HIV-positive participants on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with ruxolitinib. Appropriate studies will be undertaken in participants receiving combination antiretroviral therapy when indicated.
  • Prior or current treatment with a JAK inhibitor, for any indication.
  • Known Hepatitis B or C participants
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kristen Otte 713-798-8874 clinical-research@breastcenter.tmc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02928978
Other Study ID Numbers  ICMJE H-38855
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Julie Nangia, Baylor Breast Care Center
Study Sponsor  ICMJE Julie Nangia
Collaborators  ICMJE
  • Incyte Corporation
  • Translational Breast Cancer Research Consortium
Investigators  ICMJE Not Provided
PRS Account Baylor Breast Care Center
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP