Washington University School of Medicine
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).
Inclusion Criteria for both Phase Ib and Phase II: * Hormone receptor-positive, HER2-negative metastatic breast cancer. * Measurable or non-measurable but evaluable disease by RECIST v1.1. * Candidate for capecitabine treatment per physician decision. See below phase-specific eligibility criteria for further guidance. * No more than one prior chemotherapy for metastatic disease. * Patient must have received prior endocrine therapy with CDK4/6 inhibitor. * If patient is on denosumab or zoledronic acid prior to enrollment, patient must have been on the regimen for at least 6 months prior to stu…
Patients should take zunsemetinib at approximately the same times every day, with or without food with 8 oz of water.
Patients should take capecitabine at approximately the same times every day, within 30 minutes after a meal.
Standard of care. Will receive zoledronic acid or denosumab.
Standard of care. Will receive zoledronic acid or denosumab.
Arctuva estimate
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