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Trial record 1 of 1 for:    NCT02928978
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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 : February 27, 2019
Sponsor:
Collaborators:
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: Prevention
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 3, 2018
Estimated Primary Completion Date : January 2022
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
ruxolitinib tablet
Other Names:
  • Jakafi
  • INCB018424 Phosphate

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)
placebo tablet




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
Criteria

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.

    • 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 Cockroft-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.
  • 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

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


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

Locations
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United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Kristen Otte    713-798-8874    clinical-research@breastcenter.tmc.edu   
Principal Investigator: Julie Nangia, M.D.         
Sub-Investigator: Mothaffar Rimawi, M.D.         
Sub-Investigator: Matthew Ellis, M.D.         
Sub-Investigator: Maryam Nemati Shaefee, M.D.         
Sub-Investigator: C. Kent Osborne, M.D.         
Sponsors and Collaborators
Julie Nangia
Incyte Corporation
Translational Breast Cancer Research Consortium

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Responsible Party: Julie Nangia, Assistant Professor, Baylor Breast Care Center
ClinicalTrials.gov Identifier: NCT02928978     History of Changes
Other Study ID Numbers: BaylorBCC
First Posted: October 10, 2016    Key Record Dates
Last Update Posted: February 27, 2019
Last Verified: February 2019
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
ALH
ADH
DCIS
LCIS
Breast Cancer Prevention
Ruxolitinib

Additional relevant MeSH terms:
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Carcinoma
Hyperplasia
Carcinoma in Situ
Carcinoma, Ductal
Carcinoma, Intraductal, Noninfiltrating
Breast Diseases
Precancerous Conditions
Carcinoma, Lobular
Breast Carcinoma In Situ
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pathologic Processes
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary
Skin Diseases
Breast Neoplasms
Neoplasms by Site