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NCT06374459 · ClinicalTrials.gov registry record · Phase 1
Zunsemetinib in Combination With Capecitabine in Patients With Hormone Receptor-Positive and HER2-Negative Metastatic Breast Cancer With Bone Metastasis
A Phase 1 study of Hormone Receptor Positive HER-2 Negative Metastatic Breast Cancer, sponsored by Washington University School of Medicine.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 152
- Enrollment target
- 3
- Study locations
NCT06374459: Recruiting Phase 1 study of Hormone Receptor Positive HER-2 Negative Metastatic Breast Cancer, sponsored by Washington University School of Medicine.
NCT06374459 is a Phase 1 study of Hormone Receptor Positive HER-2 Negative Metastatic Breast Cancer that is actively recruiting participants, run by Washington University School of Medicine. The registered enrollment target is 152 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (153% higher). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06374459, a Phase 1 study of Hormone Receptor Positive HER-2 Negative Metastatic Breast Cancer, is actively recruiting participants, sponsored by Washington University School of Medicine.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 152 participants
- Enrollment target
- 3
- Study locations
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).
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 152 participants |
| Start Date | 2025-01-30 |
| Est. Completion | 2032-05-31 |
| Phase | Phase 1 |
What NCT06374459 shows while recruiting
NCT06374459 is an interventional study that assigns participants to a tested intervention. The registered 152 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (153% higher).
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.
NCT06374459 reports a single indexed study location in Kansas, Minnesota, Missouri.
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.
What interventions are being tested in trial NCT06374459?
The interventions under investigation include: Capecitabine (DRUG), Zumsemetinib (DRUG), Zoledronic acid (DRUG), Denosumab (DRUG).
Who is sponsoring clinical trial NCT06374459?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06374459's enrollment target sits among peer trials
152 360th of 2000 higher than 1,638 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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