RecruitingEarly Phase 1NCT06008275

Neratinib in Combination With Ruxolitinib in Patients With mTNBC

Pilot Clinical Trial Examining the Safety and Efficacy of Neratinib in Combination With Ruxolitinib in Patients With Chemotherapy-pretreated Metastatic Triple Negative Breast Cancer With Chest Wall Recurrence


Sponsor

Baylor Research Institute

Enrollment

20 participants

Start Date

Sep 16, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying a combination of two drugs — neratinib and ruxolitinib — for women with metastatic triple-negative breast cancer (TNBC), a type of breast cancer that is harder to treat because it doesn't respond to hormone therapies. **You may be eligible if...** - You are a woman aged 18 or older - You have been diagnosed with metastatic TNBC - You have previously received standard chemotherapy (anthracycline and taxane-based), unless there was a medical reason not to - You have received no more than 4 prior chemotherapy regimens for metastatic disease (or more if your doctor approves and you are in good health) - You have a tumor site that is accessible for a biopsy (breast, chest wall, lung, liver, or skin) - You are in generally good health (ECOG 0–1) **You may NOT be eligible if...** - You have more than 4 prior chemotherapy regimens and are not in good health - You are unable to safely undergo a tumor biopsy - Your blood counts or organ function are too low to safely participate - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGNeratinib Oral Tablet

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

DRUGRuxolitinib Oral Tablet

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


Locations(1)

Baylor University Medical Center, Baylor Charles A Sammons Cancer Center

Dallas, Texas, United States

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NCT06008275


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