Can a drug shrink precancerous breast cells before surgery?
NCT ID NCT02928978
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether a drug called ruxolitinib can reduce abnormal breast cells in people with high-risk or precancerous breast conditions like DCIS or atypical hyperplasia. Half of the 84 participants took ruxolitinib for about 15 days before surgery, and the other half took a placebo. Researchers compared cell death in breast tissue samples taken before and after treatment to see if the drug had an effect.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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84 people
The number who actually took part.
- Started
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May 2018
- Finished
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Sep 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Harris Health System - Smith Clinic
Houston, Texas, 77054, United States
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Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202, United States
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Montefiore Medical Center
The Bronx, New York, 10461, United States
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O'Quinn Medical Tower - McNair Campus; Dan L Duncan Comprehensive Cancer Center
Houston, Texas, 77054, United States
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University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
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University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599, United States
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University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
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Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232, United States
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Other studies related to the condition(s) this trial covers.
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