Ruxolitinib for Premalignant Breast Disease (TBCRC042)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02928978|
Recruitment Status : Recruiting
First Posted : October 10, 2016
Last Update Posted : May 12, 2022
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|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
Participants will receive ruxolitinib 20 mg by mouth twice daily for 15 days (+/- 5 days). Ruxolitinib will be supplied as four, 5 mg tablets.
tablet (taken by mouth)
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)
- 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.
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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.
- 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.
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
|Contact: Kristen Otteemail@example.com|
|United States, Alabama|
|University of Alabama at Birmingham||Recruiting|
|Birmingham, Alabama, United States, 35294|
|Contact: Shelley Hill 205-934-4173 firstname.lastname@example.org|
|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 email@example.com|
|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 firstname.lastname@example.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 email@example.com|
|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 firstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator: Parijatham Thomas, MD|
|Principal Investigator:||Julie Nangia, M.D.||Baylor College of Medicine|
|Responsible Party:||Julie Nangia, Assistant Professor, Baylor Breast Care Center|
|Other Study ID Numbers:||
|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|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Premalignant Breast Disease
Breast Cancer Prevention
Carcinoma in Situ
Carcinoma, Intraductal, Noninfiltrating
Breast Carcinoma In Situ
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Ductal, Lobular, and Medullary
Neoplasms by Site