Neratinib in Combination With Ruxolitinib in Patients With mTNBC

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexFemale
Age18+
SponsorBaylor Research Institute

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

Qualifiers

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

Treatments tested in this trial

  • Neratinib Oral Tablet
  • Ruxolitinib Oral Tablet

Treatment groups

20 Participants
are divided into 1 treatment group

Sponsors and collaborators