Ruxolitinib for Precancerous Breast Conditions

(TBCRC042 Trial)

Recruiting at8 trial locations

Overseen by Julie Nangia, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Julie Nangia

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing if ruxolitinib can change early abnormal breast cells that might turn into cancer. Some participants will take the drug for a short period, while others will not. Afterward, all participants will have surgery to remove the abnormal cells. Ruxolitinib has been evaluated in various clinical trials for treating certain types of breast cancer.

Research Team

Julie Nangia, M.D.

Principal Investigator

Baylor College of Medicine

Eligibility Criteria

This trial is for adults with certain non-invasive breast conditions like ADH, ALH, LCIS, or DCIS needing surgery. Participants must not be pregnant/nursing, HIV-positive on antiretrovirals, have had JAK inhibitors before, active hepatitis B/C, recent SERMs/aromatase inhibitors use for prevention or invasive breast cancer history within 5 years.

Inclusion Criteria

Patient understands the study regimen, its requirements, risks, and discomforts, and is able and willing to sign a written informed consent document.

My biopsy samples are available for research.

My blood and organs are functioning well.

Exclusion Criteria

I have taken medication to prevent breast cancer in the last year.

I do not have any severe illnesses that could interfere with the study.

I am not pregnant or nursing.

Treatment Details

Interventions

• Ruxolitinib (Janus Kinase (JAK) Inhibitor)
• Surgery (Procedure)

Trial Overview The study tests if ruxolitinib affects premalignant breast cells compared to a placebo. Half the participants will take ruxolitinib and half a sugar pill for about 15 days before surgical removal of the affected tissue.

Participant Groups

Group I: Ruxolitinib Experimental Treatment 1 Intervention

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

Group II: Placebo Placebo Group 1 Intervention

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).

Who Is Running the Clinical Trial?

Julie Nangia

Lead Sponsor

Trials

2

Recruited

340+

Translational Breast Cancer Research Consortium

Collaborator

Trials

27

Recruited

3,100+

Incyte Corporation

Industry Sponsor

Trials

408

Recruited

66,800+

Steven Stein

Incyte Corporation

Chief Medical Officer since 2015

MD from University of Witwatersrand

Hervé Hoppenot

Incyte Corporation

Chief Executive Officer since 2014

MBA from ESSEC Business School