Ductal Carcinoma In Situ Clinical Trial
— TBCRC042Official title:
TBCRC 042 - A Randomized Phase II Window-of-Opportunity Trial of Ruxolitinib in Patients With High Risk and Premalignant Breast Conditions
NCT number | NCT02928978 |
Other study ID # | H-38855 |
Secondary ID | |
Status | Recruiting |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | May 13, 2018 |
Est. completion date | January 2025 |
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | January 2025 |
Est. primary completion date | December 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Alabama at Birmingham | Birmingham | Alabama |
United States | Montefiore Medical Center | Bronx | New York |
United States | University of North Carolina at Chapel Hill | Chapel Hill | North Carolina |
United States | Baylor College of Medicine | Houston | Texas |
United States | University of Texas MD Anderson Cancer Center | Houston | Texas |
United States | Indiana University Melvin and Bren Simon Cancer Center | Indianapolis | Indiana |
United States | Vanderbilt-Ingram Cancer Center | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Julie Nangia | Incyte Corporation, Translational Breast Cancer Research Consortium |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Apoptosis | The number of premalignant breast cells in apoptosis at the time of diagnosis will be compared to the number of cells in apoptosis following treatment with 15 (+/- 5) days of ruxolitinib or placebo. | 15 days (+/- 5 days) | |
Secondary | pSTAT5 | To determine the difference in change in pSTAT5 levels between diagnosis and surgery as a function of ruxolitinib treatment versus placebo | 15 days (+/- 5 days) |
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