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Ruxolitinib for Premalignant Breast Disease (TBCRC042)

Primary Purpose

Ductal Carcinoma In Situ, Atypical Lobular Hyperplasia, Atypical Ductal Hyperplasia

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ruxolitinib
Placebo (for Ruxolitinib)
Sponsored by
Julie Nangia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ductal Carcinoma In Situ focused on measuring Premalignant Breast Disease, ALH, ADH, DCIS, LCIS, Breast Cancer Prevention, Ruxolitinib

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Alabama at BirminghamRecruiting
  • Indiana University Melvin and Bren Simon Cancer CenterRecruiting
  • Montefiore Medical CenterRecruiting
  • University of North Carolina at Chapel HillRecruiting
  • Vanderbilt-Ingram Cancer CenterRecruiting
  • Baylor College of MedicineRecruiting
  • University of Texas MD Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ruxolitinib

Placebo

Arm Description

Participants will receive ruxolitinib 20 mg by mouth twice daily for 15 days (+/- 5 days). Ruxolitinib will be supplied as four, 5 mg tablets.

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).

Outcomes

Primary Outcome Measures

Change in Apoptosis
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

pSTAT5
To determine the difference in change in pSTAT5 levels between diagnosis and surgery as a function of ruxolitinib treatment versus placebo

Full Information

First Posted
October 7, 2016
Last Updated
May 9, 2022
Sponsor
Julie Nangia
Collaborators
Incyte Corporation, Translational Breast Cancer Research Consortium
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1. Study Identification

Unique Protocol Identification Number
NCT02928978
Brief Title
Ruxolitinib for Premalignant Breast Disease
Acronym
TBCRC042
Official Title
TBCRC 042 - A Randomized Phase II Window-of-Opportunity Trial of Ruxolitinib in Patients With High Risk and Premalignant Breast Conditions
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 13, 2018 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Julie Nangia
Collaborators
Incyte Corporation, Translational Breast Cancer Research Consortium

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ductal Carcinoma In Situ, Atypical Lobular Hyperplasia, Atypical Ductal Hyperplasia, Lobular Carcinoma In Situ
Keywords
Premalignant Breast Disease, ALH, ADH, DCIS, LCIS, Breast Cancer Prevention, Ruxolitinib

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ruxolitinib
Arm Type
Experimental
Arm Description
Participants will receive ruxolitinib 20 mg by mouth twice daily for 15 days (+/- 5 days). Ruxolitinib will be supplied as four, 5 mg tablets.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Ruxolitinib
Other Intervention Name(s)
Jakafi, INCB018424
Intervention Description
tablet (taken by mouth)
Intervention Type
Drug
Intervention Name(s)
Placebo (for Ruxolitinib)
Intervention Description
tablet (taken by mouth)
Primary Outcome Measure Information:
Title
Change in Apoptosis
Description
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.
Time Frame
15 days (+/- 5 days)
Secondary Outcome Measure Information:
Title
pSTAT5
Description
To determine the difference in change in pSTAT5 levels between diagnosis and surgery as a function of ruxolitinib treatment versus placebo
Time Frame
15 days (+/- 5 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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. 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kristen Otte
Phone
713-798-8874
Email
clinical-research@breastcenter.tmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie Nangia, M.D.
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shelley Hill
Phone
205-934-4173
Email
shill26@uab.edu
First Name & Middle Initial & Last Name & Degree
Catherine Parker, MD
Facility Name
Indiana University Melvin and Bren Simon Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Versie Barnes
Phone
317-278-3127
Email
barnesv@iu.edu
First Name & Middle Initial & Last Name & Degree
Carla Fisher, MD
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anton Lulaj
Phone
718-405-8539
Email
alulaj@montefiore.org
First Name & Middle Initial & Last Name & Degree
Sheldon Feldman, MD
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Crissey Tait
Phone
984-974-8675
Email
crissey_tait@med.unc.edu
First Name & Middle Initial & Last Name & Degree
Kristalyn Gallagher, DO
Facility Name
Vanderbilt-Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clinical Trials Information Program
Phone
800-811-8480
First Name & Middle Initial & Last Name & Degree
Ingrid Meszoely, MD
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claudette Foreman
Phone
713-798-7315
Email
cforema@bcm.edu
First Name & Middle Initial & Last Name & Degree
Julie Nangia, M.D.
First Name & Middle Initial & Last Name & Degree
Mothaffar Rimawi, M.D.
First Name & Middle Initial & Last Name & Degree
Bora Lim, M.D.
First Name & Middle Initial & Last Name & Degree
C. Kent Osborne, M.D.
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diane Weber, RN
Phone
346-212-1287
Email
dweber@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Parijatham Thomas, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Ruxolitinib for Premalignant Breast Disease

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