OncoMatch/Clinical Trials/NCT06008275
Neratinib in Combination With Ruxolitinib in Patients With mTNBC
Is NCT06008275 recruiting? Yes, currently enrolling (May 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
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)
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
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