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 (Jun 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
Treatments studied
Targeted therapy
Chemotherapy
Other
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 →Frequently asked questions
Is NCT06374459 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior capecitabine disqualifies patients from enrollment.
Does this trial require ESR1?
Yes, ESR1 hormone receptor-positive is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 HER2-negative is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages