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

Sponsored by Washington University School of Medicine

Quick Self-Assessment

See if you qualify and express your interest

Preparing your pre-screening questions...

Current Status

Recruiting

Auto-verified from ClinicalTrials.gov

Verified Feb 9, 2026

Phase

Clinical Trial

Sponsor

Washington University School of Medicine

Enrollment Target

152

Start Date

Jan 2025

๐Ÿ“Š
1 of 152 participants interested
1% interest

Express Your Interest Today

Interested in learning more? Complete the form below.

Secure & Confidential

Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Advance Medical Science

    Contribute to groundbreaking research

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel (varies by study)

  • Help Others

    Benefit future patients

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3In-person assessment if eligible
  4. 4Begin participation

About This Study

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).

Who Can Participate

Inclusion Criteria

for both Phase Ib and Phase II:
Hormone receptor-positive, HER2-negative metastatic breast cancer.
Measurable or non-measurable but evaluable disease by RECIST v1.1.
Candidate for capecitabine treatment per physician decision. See below phase-specific eligibility criteria for further guidance.
No more than one prior chemotherapy for metastatic disease.
Patient must have received prior endocrine therapy with CDK4/6 inhibitor.
If patient is on denosumab or zoledronic acid prior to enrollment, patient must have been on the regimen for at least 6 months prior to study. However, a washout of 3 weeks is required prior to C1D1.
At least 18 years of age.
ECOG performance status 0, 1, or 2
Life expectancy of at least 12 weeks.
Adequate bone marrow and organ function as defined below:
Leukocytes โ‰ฅ 3 K/cumm
Absolute neutrophil count (ANC) โ‰ฅ 1.5 K/cumm
Platelets โ‰ฅ 100 K/cumm
Total bilirubin โ‰ค 1.5 x IULN (or total bilirubin โ‰ค 3 mg/dL if patie

โ“ Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility during the screening process.

Study Details

๐Ÿ“‹

Study Type

INTERVENTIONAL

๐Ÿ‘ฅ

Target Enrollment

152 participants

โšง

Gender

ALL

๐Ÿข

Sponsor

Washington University School of Medicine

Study Locations

Choose your preferred location or select flexible during enrollment

RECRUITING

Westwood

Kansas

Location available
View Westwood location page
NOT_YET_RECRUITING

Rochester

Minnesota

Location available
View Rochester location page
RECRUITING

St Louis

Missouri

Location available
View St Louis location page

Frequently Asked Questions

Q:What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Q:Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Q:Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Q:Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

Q:How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Still have questions? Our study coordinators are here to help.

Ready to Make a Difference?

Express your interest in this groundbreaking clinical trial

๐Ÿ”’ Secure ยท ๐Ÿฅ Expert Care

Find More Breast Cancer Trials by City

Browse all breast cancer clinical trials in these cities โ€” not just this study.

Looking for Breast Cancer Treatment in Westwood?

Join others in Kansas exploring innovative treatment options through clinical research

Breast Cancer Treatment Options in Westwood, Kansas

If you're searching for Breast Cancer treatment in Westwood, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Westwood, Rochester, St Louis and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Breast Cancer. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Kansas
Now Enrolling
Up to 152 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Breast Cancer?

Potential Benefits

  • โœ“Access to new treatment approaches before public availability
  • โœ“Close monitoring by experienced medical professionals
  • โœ“Study-related care provided at no cost
  • โœ“Contribute to medical research for Breast Cancer

What to Expect

  • โ†’Initial screening to determine eligibility
  • โ†’Regular check-ups and monitoring visits
  • โ†’Possible compensation for time and travel
  • โ†’You can withdraw at any time

Frequently Asked Questions About This Breast Cancer Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT06374459. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.