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RECRUITING Phase 1

Zunsemetinib in Combination With Capecitabine in Patients With Hormone Receptor-Positive and HER2-Negative Metastatic Breast Cancer With Bone Metastasis

NCT06374459 · View on ClinicalTrials.gov ↗

Study 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).

Interventions

  • DRUG Capecitabine
  • DRUG Zumsemetinib
  • DRUG Zoledronic acid
  • DRUG Denosumab

Study Locations (3)

Kansas

  • The University of Kansas Cancer Center — Westwood

Minnesota

  • Mayo Clinic — Rochester

Missouri

  • Washington University School of Medicine — St Louis

Trial Details

FieldValue
Enrollment Target 152 participants
Start Date 2025-01-30
Est. Completion 2032-05-31
Phase Phase 1

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06374459

The ClinicalTrials.gov registry entry for NCT06374459 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 152 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,036 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Hormone Receptor Positive HER-2 Negative Metastatic Breast Cancer appearing as the primary indexed condition, and to 4 interventions — of which Capecitabine is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06374459 reports 3 study locations spanning 3 distinct geographic areas — top geographies include Kansas, Minnesota, Missouri. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06374459 about?

NCT06374459 is a clinical study titled "Zunsemetinib in Combination With Capecitabine in Patients With Hormone Receptor-Positive and HER2-Negative Metastatic Breast Cancer With Bone Metastasis". 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).

What is the current status of trial NCT06374459?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 152 participants. The study started on 2025-01-30. Estimated completion is 2032-05-31.

What conditions does trial NCT06374459 study?

This clinical trial studies the following conditions: Hormone Receptor Positive HER-2 Negative Metastatic Breast Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06374459?

The interventions under investigation include: Capecitabine (DRUG), Zumsemetinib (DRUG), Zoledronic acid (DRUG), Denosumab (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06374459?

This trial is sponsored by Washington University School of Medicine, which has 1,036 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06374459 being conducted?

This trial has 3 study locations across Kansas, Minnesota, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial