Ductal Carcinoma In SituPhase 2TBCRC042NCT02928978
Ruxolitinib for Premalignant Breast Disease
A Phase 2 study testing Ruxolitinib in people with Ductal Carcinoma In Situ and Atypical Lobular Hyperplasia, run by Julie Nangia at 8 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ductal Carcinoma In Situ, Atypical Lobular Hyperplasia, Atypical Ductal Hyperplasia
- What is being tested?
- Ruxolitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 8 sitesUnited States
- Study dates
- 13 May 2018to 18 Sep 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
University of Alabama at Birmingham
Birmingham, Alabama, 35294
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Harris Health System - Smith Clinic
Houston, Texas, 77054
O'Quinn Medical Tower - McNair Campus; Dan L Duncan Comprehensive Cancer Center
Houston, Texas, 77054
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, 46202
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232
Montefiore Medical Center
The Bronx, New York, 10461
About this study
Official title: TBCRC 042 - A Randomized Phase II Window-of-Opportunity Trial of Ruxolitinib in Patients With High Risk and Premalignant Breast Conditions
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.
- Conditions
- Ductal Carcinoma In Situ, Atypical Lobular Hyperplasia, Atypical Ductal Hyperplasia, Lobular Carcinoma In Situ
- Being tested
- Ruxolitinib, Placebo (for Ruxolitinib)
- Keywords
- Premalignant Breast Disease, ALH, ADH, DCIS, LCIS, Breast Cancer Prevention, Ruxolitinib
- Medical subject headings
- Carcinoma, Intraductal, Noninfiltrating, Breast Carcinoma In Situ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RuxolitinibDrug
Also called Jakafi, INCB018424
tablet (taken by mouth)
Placebo (for Ruxolitinib)Drug
tablet (taken by mouth)
| Study group | Role | What they receive |
|---|---|---|
| Ruxolitinib | Experimental | Participants will receive ruxolitinib 20 mg by mouth twice daily for 15 days (+/- 5 days). Ruxolitinib will be supplied as four, 5 mg tablets. Receives: Drug: Ruxolitinib |
| Placebo | Placebo comparator | 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). Receives: Drug: Placebo (for Ruxolitinib) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Percent of Apoptotic Cells
The percent of premalignant breast cells in apoptosis at the time of diagnosis will be compared to the percent of cells in apoptosis following treatment with 15 (+/- 5) days of ruxolitinib or placebo. The percent of apoptotic cells is calculated for each time point's corresponding evaluable lesion tissue sample as: 100*(number of premalignant breast cells expressing the CC3 biomarker, as determined by CC3 staining/total number of premalignant breast cells in sample).
Measured: 15 days (+/- 5 days)
Secondary outcomes (1)
Proliferation/Apoptosis Biomarkers
To determine the difference in change in proliferation/apoptosis biomarker levels between diagnosis and surgery as a function of ruxolitinib treatment versus placebo. Example biomarkers include: pSTAT5, TUNEL, Ki67, BclXL, Mcl1, Bcl2, PRLR, pSTAT3, and serum prolactin.
Measured: 15 days (+/- 5 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2016 (estimated)
- Study start13 May 2018
- Primary completion29 Aug 2024
- Study completion18 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ductal Carcinoma In SituStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Julie Nangia
- Sponsor type
- University, hospital or other
- Collaborators
- Incyte Corporation, Translational Breast Cancer Research Consortium
- Responsible party
- Sponsor-investigator, Julie Nangia, Baylor Breast Care Center
- Investigators
- Julie Nangia, M.D., Principal investigator, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02928978
- Sponsor's protocol ID
- H-38855
- Acronym
- TBCRC042
- Status last verified
- Sep 2026
- First submitted
- 7 Oct 2016
- Last updated
- 16 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TBCRC 042 - A Randomized Phase II Window-of-Opportunity Trial of Ruxolitinib in Patients With High Risk and Premalignant Breast Conditions
- ClinicalTrials.gov ID
- NCT02928978
- Acronym / sponsor ID
- TBCRC042 / H-38855
- Conditions
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Julie NangiaUniversity, hospital or other
- Collaborators
- Incyte Corporation, Translational Breast Cancer Research Consortium
- Study start
- 13 May 2018 (actual)
- Primary completion
- 29 Aug 2024 (actual)
- Study completion
- 18 Sep 2024 (actual)
- First posted
- 10 Oct 2016 (estimated)
- Results
- Posted 16 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ruxolitinib | Experimental | Drug: RuxolitinibParticipants will receive ruxolitinib 20 mg by mouth twice daily for 15 days (+/- 5 days). Ruxolitinib will be supplied as four, 5 mg tablets. |
| Placebo | Placebo comparator | Drug: Placebo (for Ruxolitinib)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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
- Women and men age 18 and older.
- Adequate hematologic and organ function, defined as follows:
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RuxolitinibAlso: Jakafi, INCB018424tablet (taken by mouth) | Drug | Ruxolitinib |
| Placebo (for Ruxolitinib)tablet (taken by mouth) | Drug | Placebo |
Primary outcome
Change in Percent of Apoptotic Cells
Time frame: 15 days (+/- 5 days)
The percent of premalignant breast cells in apoptosis at the time of diagnosis will be compared to the percent of cells in apoptosis following treatment with 15 (+/- 5) days of ruxolitinib or placebo. The percent of apoptotic cells is calculated for each time point's corresponding evaluable lesion tissue sample as: 100*(number of premalignant breast cells expressing the CC3 biomarker, as determined by CC3 staining/total number of premalignant breast cells in sample).
1 secondary outcome
Proliferation/Apoptosis Biomarkers
Time frame: 15 days (+/- 5 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julie Nangia, M.D. principal investigator
Baylor College of Medicine
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ruxolitinib in people with Ductal Carcinoma In Situ and Atypical Lobular Hyperplasia, run by Julie Nangia at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Percent of Apoptotic Cells (time frame: 15 days (+/- 5 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.