Phase 1/2Recruiting
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 (Academic or other)
- Enrolment
- 152 planned
- Conditions
- Hormone Receptor Positive HER-2 Negative Metastatic Breast Cancer
- Interventions
- Zumsemetinib; Capecitabine; Zoledronic acid; Denosumab
- Ages
- adults, older adults
- Registry
- NCT06374459
Full record on ClinicalTrials.gov
From the registry
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).
Primary outcomes
- Number of participants with adverse events (Phase Ib only)
- Recommended phase II dose of zunsemetinib (Phase Ib only)
- Number of participants with dose-limiting toxicities (Phase Ib only)
- Percent change in serum CTX (Phase II only)
History
Primary completion expected
Last registry update
Started
Registered