RecruitingPhase 1Phase 2NCT06374459

Zunsemetinib in Combination With Capecitabine in Patients With Hormone Receptor-Positive and HER2-Negative Metastatic Breast Cancer With Bone Metastasis

A Phase Ib/II Trial of Zunsemetinib in Combination With Capecitabine in Patients With Hormone Receptor-Positive and HER2-Negative Metastatic Breast Cancer With Bone Metastasis


Sponsor

Washington University School of Medicine

Enrollment

152 participants

Start Date

Jan 30, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a phase Ib/II study evaluating the safety and efficacy of zunsemetinib (ATI-450) with capecitabine in patients with hormone receptor-positive and HER2-negative (HR+/HER2-) metastatic breast cancer (MBC).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a combination of a new drug (zunsemetinib, a p38/MK2 pathway inhibitor) with a standard chemotherapy called capecitabine, for people with hormone receptor-positive, HER2-negative metastatic breast cancer that has spread to the bones. The hope is that targeting this pathway may help overcome resistance to standard therapies. **You may be eligible if...** - You are 18 or older with hormone receptor-positive, HER2-negative metastatic breast cancer and bone metastases - You have already received endocrine therapy plus a CDK4/6 inhibitor - You have not received more than one prior chemotherapy for metastatic disease - Your overall health status allows treatment (ECOG 0–2) and you have at least 12 weeks life expectancy **You may NOT be eligible if...** - You have had more than one prior chemotherapy regimen for metastatic disease - You haven't yet tried endocrine therapy with CDK4/6 inhibitor - You have serious heart, liver, or kidney problems that prevent safe treatment 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

DRUGZumsemetinib

Patients should take zunsemetinib at approximately the same times every day, with or without food with 8 oz of water.

DRUGCapecitabine

Patients should take capecitabine at approximately the same times every day, within 30 minutes after a meal.

DRUGZoledronic acid

Standard of care. Will receive zoledronic acid or denosumab.

DRUGDenosumab

Standard of care. Will receive zoledronic acid or denosumab.


Locations(3)

The University of Kansas Cancer Center

Westwood, Kansas, United States

Mayo Clinic

Rochester, Minnesota, United States

Washington University School of Medicine

St Louis, Missouri, United States

View Full Details on ClinicalTrials.gov

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NCT06374459