About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Has peripheral neuropathy ≥grade 2
Has completed previous radiotherapy for metastatic disease <2 weeks prior to study treatment initiation
Has an active infection requiring systemic therapy
Trial design
Single group
Treatments tested in this trial
Neratinib Oral Tablet
Drug240mg oral daily. Dosing will follow standard dose escalation procedures
Ruxolitinib Oral Tablet
Drug20mg oral twice daily. Dosing will follow standard initial dose recommendation procedure
Treatment groups
Trial outcomes
Primary outcomes
Objective Response Rate
Calculate objective response rate (CR+PR) associated with neratinib in combination ruxolitinib. Objective response rate will be calculated by defining the proportion of patients who have a complete or partial response to the study therapy, as determined by the treating physician.
Secondary outcomes
Duration of Response
Calculate duration of response associated with neratinib in combination with ruxolitinib. Duration of response will be calculated from the time of tumor response to disease progression in patients responding to study therapy
Other outcomes
Genetic Evaluation
Signaling signatures of research biopsies will be analyzed via Next Generation Sequencing and Reverse Phase Protein Array
Sponsors and contacts
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