A Randomized Phase II Window-of-opportunity Trial of Ruxolitinib in Patients with High Risk and Premalignant Breast Conditions

C
Carla Fisher, MD

Primary Investigator

Administratively Closed
18 years - 100 years
All
Phase 2
6 participants needed
5 Locations

Brief description of study

What is the purpose of this study?
This study is being done in order to see how ruxolitinib changes the breast cell when administered to participants with premalignant breast conditions.
 
THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic. 
 

 
Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office 
Phone: (317) 278-5632

Detailed description of study

What will happen during the study?
  • Participants will first complete screening: tests/procedures considered standard treatment for premalignant breast disease, plus a research blood draw.
  • If eligible, participants will then be randomly assigned to receive either Ruxolitinib 20 mg, or placebo, twice daily for 10-20 days followed by surgery.
  • Participants will complete a pre-surgery visit, to include: blood test, review of medications, review of side effects.
  • Participants will return to the clinic about 2-4 weeks after surgery as part of routine care for premalignant breast condition. During this visit, participants will complete a physical exam, review of medications, and pill count to verify how many doses of the study medication were taken.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Ductal Carcinoma In Situ, Atypical Lobular Hyperplasia, Atypical Ductal Hyperplasia, Lobular Carcinoma In Situ
  • Age: 18 years - 100 years
  • Gender: All

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.

Updated on 27 Jan 2025. Study ID: TBCRC042, 1905869883

Interested in the study?

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