Clinical trial · Interventional
Ruxolitinib in Patients With Breast Cancer
Phase II Study of Ruxolitinib (INCB018424) in Patients With PSTAT3+ Breast Cancer
NCT01562873CI-TRIAL-00026066terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Not enough responses to continue treatment.
Summary
Brief summary (as posted)
Ruxolitinib is a drug which blocks the Janus tyrosine Kinase (JAK) signaling pathway. It is thought that this pathway might be important in certain types of breast cancer, and that blocking this pathway might lead to anti-cancer effects. This study is testing the effects of ruxolitinib in patients with breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ruxolitinib | Drug | Ruxolitinib | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Ruxolitinib-Cohort A
- description
- Patients received Ruxolitinib 25 mg twice daily for up to 12 cycles (cycle duration=28 days) until evidence of disease progression or unacceptable toxicity. Patients enrolled sequentially into two possible cohorts based on pStat3+ expression score by central testing: Cohort A - moderate to high positive status defined as a score of \>/=5 by central testing or Cohort B - low positive status defined as a score of 3-4. Each cohort was evaluated with a 2 stage design. Cohort B only opened if 2 objective responses were observed in 1st stage Cohort A patients (n=21).
- interventionNames
- Drug: Ruxolitinib
- type
- EXPERIMENTAL
- label
- Ruxolitinib-Cohort B
- description
- Patients received Ruxolitinib 25 mg twice daily for up to 12 cycles (cycle duration=28 days) until evidence of disease progression or unacceptable toxicity. Patients enrolled sequentially into two possible cohorts based on pStat3+ expression score by central testing: Cohort A - moderate to high positive status defined as a score of \>/=5 by central testing or Cohort B - low positive status defined as a score of 3-4. Each cohort was evaluated with a 2 stage design. Cohort B only opened if 2 objective responses were observed in 1st stage Cohort A patients (n=21).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed invasive breast cancer * Must have known ER, PR and HER2 status * Either, Triple Negative Metastatic Breast Cancer or * Inflammatory Breast Cancer with any ER, PR HER2 status * Availability of archival tissue specimen suitable for pStat3 testing * Life expectancy of greater than 3 months * Measurable disease by RECIST * At least one prior chemotherapy regimen for treatment of metastatic breast cancer and/or recurrence within 12 months of completion of neoadjuvant/adjuvant chemotherapy or * For patients with inflammatory breast cancer but no distant metastases, progression through standard neoadjuvant chemotherapy is required Exclusion Criteria: * Pregnant or breastfeeding * Active brain metastases * History of allergic reactions attributed to compounds of similar chemical or biologic composition to ruxolitinib * Clinically significant malabsorption syndrome * Concurrent use of medications/substances that are strong inhibitors of CY3A4 * No uncontrolled intercurrent illness
References
Publications (0)
Data not yet available
No reference posted for this study.