Neratinib in Combination With Ruxolitinib in Patients With mTNBC (NCT06008275) | Clinical Trial Compass
RecruitingEarly Phase 1
Neratinib in Combination With Ruxolitinib in Patients With mTNBC
United States20 participantsStarted 2024-09-16
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
✓. Female patients ≥18 years of age
✓. 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.
✓. 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.
✓. Have locoregional (e.g., breast, chest wall, regional lymphatic) or pulmonary or hepatic metastatic disease that is amenable to core needle biopsy. If a research biopsy from a patient's metastatic disease cannot be safely obtained, a skin biopsy is permitted. If a skin biopsy cannot be safely obtained, patients may still be eligible, per physician discretion.
✓. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
✓. Have adequate hematologic function, defined by:
✓. Absolute neutrophil count (ANC) \>1500/µL
✓. Platelet count ≥100,000/ µL
Exclusion criteria
✕. Has received a live vaccine or live-attenuated vaccine within 30 days of the first dose of study treatment. Administration of killed vaccines is allowed.