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
Washington University School of Medicine
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
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 CenterWestwood, Kansas
- Mayo ClinicRochester, Minnesota
- Washington University School of MedicineSt Louis, Missouri