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Can a drug shrink precancerous breast cells before surgery?

NCT ID NCT02928978

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

84 people

The number who actually took part.

Started

May 2018

Finished

Sep 2024

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • Harris Health System - Smith Clinic

    Houston, Texas, 77054, United States

  • Indiana University Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202, United States

  • Montefiore Medical Center

    The Bronx, New York, 10461, United States

  • O'Quinn Medical Tower - McNair Campus; Dan L Duncan Comprehensive Cancer Center

    Houston, Texas, 77054, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294, United States

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599, United States

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030, United States

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.