Phase 2
N=20
Ruxolitinib W/ Preop Chemo For Triple Negative Inflammatory Brca
Recurrent Breast Cancer · Metastatic Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02041429 ↗Enrolled (actual)
20
Serious AEs
45.0%
Results posted
Apr 2021
Primary outcome: Primary: Ruxolitinib Maximum Tolerated Dose (MTD) [Phase I] — 15 mg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ruxolitinib (Drug); Paclitaxel (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Dana-Farber Cancer Institute
- Primary completion
- May 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ruxolitinib Maximum Tolerated Dose (MTD) [Phase I] |
15 | — |
| PRIMARY Number of Participants With Dose Limiting Toxicity (DLT) [Phase I] |
0; 0; 1; 0 | — |
| SECONDARY Best Response [Phase I] |
0; 0; 0; 0; 1; 0 | — |
| SECONDARY All-Cause Neutropenia |
2; 1; 5; 3 | — |
| SECONDARY C-Reactive Protein Change From Baseline |
-1.6; -4.3; -9.7; 0.45 | — |
| SECONDARY IL-6 Change From Baseline |
0; -0.2; -2.7; 0.6 | — |
Summary
This phase I/II research study is evaluating a combination of drugs called paclitaxel and ruxolitinib as a possible treatment for inflammatory breast cancer. Ruxolitinib is a newly discovered drug that has been shown to block a pathway (called the IL6/JAK/Stat pathway) that may be important in cancer, including breast cancer. Blocking this pathway may stop cancer cells from growing. Ruxolitinib has been approved by the FDA for patients with bone marrow disease, and this is the first study using this drug in combination with paclitaxel for breast cancer. Paclitaxel (also called Taxol) is an FDA drug approved for breast cancer patients. Paclitaxel works by blocking the small microtubules inside cancer cells and preventing cell growth. Information from laboratory experiments suggests that ruxolitinib might also have effects on breast cancer.These studies have shown that ruxolitinib may make paclitaxel more effective.
Eligibility Criteria
Inclusion Criteria
Phase I
- Participants must meet the following criteria on screening examination to be eligible to participate in the study:
- Participants must have histologically confirmed breast cancer that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective.
- Patients may not have received > 2 prior chemotherapies for advanced disease.
- Either measurable or evaluable disease is allowed.
- Age ≥18 years. Because no dosing or adverse event data are currently available on the use of ruxolitinib in participants 4 weeks) brain metastasis are allowed.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to ruxolitinib.
- Participants receiving any medications or substances that are strong inhibitors of CYP3A4 are ineligible. (Please refer to Appendix B for list and washout periods).
- Chronic corticosteroid use in excess of the equivalent of prednisone 10 mg once daily.
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant women are excluded from this study because ruxolitinib is a JAK inhibitor with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with ruxolitinib, breastfeeding should be discontinued if the mother is treated with ruxolitinib. These potential risks may also apply to other agents used in this study.
- Individuals with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 3 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 3 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.
- Clinically significant malabsorption syndrome.
- Prior chemotherapy or radiation administered within 2 weeks from initiating study treatment.
Data sourced from ClinicalTrials.gov (NCT02041429). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.