Actively Recruiting
Neratinib in Combination With Ruxolitinib in Patients With mTNBC
Led by Baylor Research Institute · Updated on 2025-11-10
20
Participants Needed
1
Research Sites
115 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The goal of this clinical trial is to assess the safety and efficacy of combined ruxolitinib and neratinib in patients with chemotherapy-pretreated metastatic triple negative breast cancer. This trial will evaluate one dosing schedule of neratinib in ruxolitinib in patients with metTNBC with locoregional recurrence.
CONDITIONS
Official Title
Neratinib in Combination With Ruxolitinib in Patients With mTNBC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female patients 18 years of age or older
- Diagnosis of metastatic triple negative breast cancer previously treated with standard anthracycline, cyclophosphamide, and taxane chemotherapy unless contraindicated
- No more than 4 prior chemotherapy regimens for metastatic disease; exceptions may be made if ECOG performance status is 0-1
- Locoregional or pulmonary or hepatic metastatic disease suitable for core needle or skin biopsy; exceptions per physician discretion
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Adequate blood cell counts: neutrophils >1500/µL, platelets ≥100,000/µL, hemoglobin ≥9 g/dL
- Adequate liver function with AST and ALT ≤2.5 times upper limit of normal or ≤5 times with liver metastases; total bilirubin ≤1.5 times upper limit of normal or direct bilirubin normal if total bilirubin >1.5 times
- Adequate kidney function with serum creatinine ≤1.5 times upper limit of normal or creatinine clearance ≥30 mL/min
- History of treated brain metastases with no progression, off steroids and no need for dexamethasone or anti-epileptic drugs
- Accessible for treatment and follow-up
- Able to understand the investigational nature of the study and provide written informed consent
You will not qualify if you...
- Received live vaccine within 30 days prior to first study dose
- Peripheral neuropathy grade 2 or higher
- Completed radiotherapy for metastatic disease less than 2 weeks before study treatment
- Active infection requiring systemic therapy
- Significant cardiovascular disease including recent myocardial infarction or advanced heart failure
- Known active tuberculosis
- Pregnant or breastfeeding; must agree to use effective contraception during and for 3 months after study treatment
- Severe or uncontrolled medical conditions affecting participation such as severely impaired lung function or advanced liver disease
- Conditions or abnormalities that could interfere with study results or participation as determined by physician
- Received systemic anti-cancer therapy within 2 weeks prior to study treatment
- Received investigational agents within 4 weeks prior to study treatment
- Use of other investigational or anti-cancer treatments during the study
- Presence of any other active malignancy
AI-Screening
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Trial Site Locations
Total: 1 location
1
Baylor University Medical Center, Baylor Charles A Sammons Cancer Center
Dallas, Texas, United States, 75246
Actively Recruiting
Research Team
P
Page E Blas, MA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
1
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