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

NCT06374459 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 152

Last updated 2026-04-20

No results posted yet for this 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

  • Hormone Receptor Positive HER-2 Negative Metastatic Breast Cancer

Interventions

DRUG

Zumsemetinib

Patients should take zunsemetinib at approximately the same times every day, with or without food with 8 oz of water.

DRUG

Capecitabine

Patients should take capecitabine at approximately the same times every day, within 30 minutes after a meal.

DRUG

Zoledronic acid

Standard of care. Will receive zoledronic acid or denosumab.

DRUG

Denosumab

Standard of care. Will receive zoledronic acid or denosumab.

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Aclaris Therapeutics, Inc.

    collaborator INDUSTRY

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Cynthia X Ma, M.D., Ph.D. · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-30
Primary Completion
2032-05-31
Completion
2032-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06374459 on ClinicalTrials.gov