OncoMatch/Clinical Trials/NCT06374459
Zunsemetinib in Combination With Capecitabine in Patients With Hormone Receptor-Positive and HER2-Negative Metastatic Breast Cancer With Bone Metastasis
Is NCT06374459 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Zumsemetinib and Capecitabine for hormone receptor positive her-2 negative metastatic breast cancer.
Treatment: Zumsemetinib · Capecitabine · Zoledronic acid · Denosumab — 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).
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 hormone receptor-positive
Hormone receptor-positive
Required: HER2 (ERBB2) HER2-negative
HER2-negative
Disease stage
Metastatic disease required
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: endocrine therapy
Patient must have received prior endocrine therapy
Must have received: CDK4/6 inhibitor
Patient must have received prior endocrine therapy with CDK4/6 inhibitor
Cannot have received: capecitabine (capecitabine)
Exception: Phase Ib: capecitabine is not counted as a prior chemotherapy regimen in these patients; Phase II: prior capecitabine in the metastatic setting excluded
Prior capecitabine in the metastatic setting [Phase II exclusion]; capecitabine is not counted as a prior chemotherapy regimen in these patients [Phase Ib]
Lab requirements
Blood counts
Leukocytes ≥ 3 K/cumm; ANC ≥ 1.5 K/cumm; Platelets ≥ 100 K/cumm
Kidney function
Creatinine clearance > 60 mL/min by Cockcroft-Gault
Liver function
Total bilirubin ≤ 1.5 x IULN (or ≤ 3 mg/dL if Gilbert Syndrome); AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN
Adequate bone marrow and organ function as defined below: Leukocytes ≥ 3 K/cumm; ANC ≥ 1.5 K/cumm; Platelets ≥ 100 K/cumm; Total bilirubin ≤ 1.5 x IULN (or ≤ 3 mg/dL if Gilbert Syndrome); AST(SGOT)/ALT(SGPT) ≤ 3.0 x IULN; Creatinine clearance > 60 mL/min by Cockcroft-Gault; Calcium within normal limits
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- The University of Kansas Cancer Center · Westwood, Kansas
- Mayo Clinic · Rochester, Minnesota
- Washington University School of Medicine · St Louis, Missouri
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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