Neratinib and Ruxolitinib for Metastatic Triple-Negative Breast Cancer

This study is testing a combination of two oral medications, neratinib and ruxolitinib, for women with metastatic triple-negative breast cancer (mTNBC). This is a type of breast cancer that doesn't respond to common hormone or HER2-targeted therapies. You may be able to join if you are a woman aged 18 or older with mTNBC that has been previously treated with standard chemotherapy. The researchers want to see how safe and effective this drug combination is, especially for chest wall recurrence. They will measure how many patients respond to the treatment over 18 months. The study is looking for about 20 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll about 20 participants.
What's involved
Participants will take neratinib once daily and ruxolitinib twice daily. Dosing for neratinib will follow standard dose escalation procedures.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, Objective Response Rate, will be measured at 18 months.

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NCT06008275

Neratinib in Combination With Ruxolitinib in Patients With mTNBC

Recruiting
EARLY_PHASE1Ages 18+InterventionalHealth services
Baylor Research Institute
~20 participants
Updated 2025-11-10 on ClinicalTrials.gov
What's tested:Neratinib Oral TabletRuxolitinib Oral Tablet

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Objective Response Rate
Measured over 18 months
Metastatic Triple-Negative Breast Carcinoma
Breast Cancer
1 sites across 1 states
Texas1
  • Joyce A O'Shaughnessy, MD · PRINCIPAL_INVESTIGATOR · Baylor Scott & White The Heart Hospital

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Eligibility criteria

Inclusion

A patient will be considered for enrollment in this study if all the following criteria are met:
  • Objective Response Rate18 months

    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.