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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Neratinib Oral Tablet

    Drug

    240mg oral daily. Dosing will follow standard dose escalation procedures

  • Ruxolitinib Oral Tablet

    Drug

    20mg oral twice daily. Dosing will follow standard initial dose recommendation procedure

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: neratinib + ruxolitinibExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
18 months

Secondary outcomes

1

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

Time frame
18 months

Other outcomes

1

Genetic Evaluation

Signaling signatures of research biopsies will be analyzed via Next Generation Sequencing and Reverse Phase Protein Array

Time frame
18 months

Sponsors and contacts

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