OncoMatch/Clinical Trials/NCT06008275
Neratinib in Combination With Ruxolitinib in Patients With mTNBC
Is NCT06008275 recruiting? Yes, currently enrolling (Jun 2026). This Early Phase 1 trial studies multiple treatments including Neratinib Oral Tablet and Ruxolitinib Oral Tablet for metastatic triple-negative breast carcinoma.
Treatment: Neratinib Oral Tablet · Ruxolitinib Oral Tablet — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Triple-Negative Breast Cancer
Breast Carcinoma
Biomarker criteria
Required: ESR1 negative (≤10% tumor nuclei immunoreactivity or ER Low Positive as per ASCO/CAP 2020) (≤10% tumor nuclei immunoreactivity or ER Low Positive as per ASCO/CAP 2020)
TNBC defined as ER-negative tumors with ≤10% tumor nuclei immunoreactivity, or "ER Low Positive" as defined by the updated ASCO/CAP guidelines 2020
Disease stage
Metastatic disease required
diagnosis of metastatic TNBC
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Must have received: anthracycline
previously treated with standard anthracycline
Must have received: cyclophosphamide (cyclophosphamide)
previously treated with standard ... cyclophosphamide
Must have received: taxane
previously treated with standard ... taxane chemotherapy
Cannot have received: systemic anti-cancer therapy
Has received prior systemic anti-cancer therapy within 2 weeks prior to study treatment
Cannot have received: investigational agents
Has received investigational agents within 4 weeks prior to study treatment. Monoclonal antibody agents should have a 4-week (28 day) washout period
Cannot have received: any other investigational or anti-cancer treatments
Any other investigational or anti-cancer treatments while participating in this study
Lab requirements
Blood counts
ANC >1500/µL; Platelet count ≥100,000/µL; Hemoglobin ≥9 g/dL or ≥5.6 mmol/L
Kidney function
Serum creatinine ≤1.5 x ULN or calculated creatinine clearance of ≥30 mL/min
Liver function
AST and ALT ≤2.5 x ULN or ≤5 x ULN in presence of liver metastases; Total bilirubin ≤1.5 x ULN OR direct bilirubin ≤ULN for patients with total bilirubin levels >1.5 × ULN
Have adequate hematologic function, defined by: Absolute neutrophil count (ANC) >1500/µL; Platelet count ≥100,000/ µL; Hemoglobin ≥9 g/dL or ≥5.6 mmol/L. Have adequate liver function, defined by: AST and ALT ≤2.5 x ULN or ≤5 x ULN in presence of liver metastases; Total bilirubin ≤1.5 x ULN OR direct bilirubin ≤ULN for patients with total bilirubin levels >1.5 × ULN. Have adequate renal function, defined by: Serum creatinine ≤1.5 x ULN or calculated creatinine clearance of ≥30 mL/min
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Baylor University Medical Center, Baylor Charles A Sammons Cancer Center · Dallas, Texas
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT06008275 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic anti-cancer therapy, investigational agents, any other investigational or anti-cancer treatments disqualifies patients from enrollment.
Does this trial require ESR1?
Yes, ESR1 negative (≤10% tumor nuclei immunoreactivity or ER Low Positive as per ASCO/CAP 2020) is a required biomarker for enrollment.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify