NCT06008275 Neratinib in Combination With Ruxolitinib in Patients With mTNBC
| NCT ID | NCT06008275 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Baylor Research Institute |
| Condition | Metastatic Triple-Negative Breast Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-09-16 |
| Primary Completion | 2026-06 |
Trial Parameters
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Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * A patient will be considered for enrollment in this study if all the following criteria are met: 1. Female patients ≥18 years of age 2. Have a diagnosis of metastatic TNBC previously treated with standard anthracycline, cyclophosphamide, and taxane chemotherapy, unless there was a contraindication to doxorubicin, in which case prior treatment with this agent is not required. Note. TNBC defined as ER-negative tumors with ≤10% tumor nuclei immunoreactivity, or "ER Low Positive" as defined by the updated ASCO/CAP guidelines 2020. 3. Have not received more than 4 prior chemotherapy regimens for metastatic disease. Prior platinum and/or taxane therapy in the adjuvant or metastatic setting is permitted. Patients with more than 4 prior regimens may be allowed on study per physician discretion, if ECOG PS is 0-1. 4. Have locoregional (e.g., breast, chest wall, regional lymphatic) or pulmonary or hepatic metastatic disease that is amenable to core needle biopsy. If a resea