Actively Recruiting
Zunsemetinib in Combination With Capecitabine in Patients With Hormone Receptor-Positive and HER2-Negative Metastatic Breast Cancer With Bone Metastasis
Led by Washington University School of Medicine · Updated on 2026-04-20
152
Participants Needed
3
Research Sites
382 weeks
Total Duration
On this page
Sponsors
W
Washington University School of Medicine
Lead Sponsor
U
United States Department of Defense
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Zunsemetinib in Combination With Capecitabine in Patients With Hormone Receptor-Positive and HER2-Negative Metastatic Breast Cancer With Bone Metastasis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Hormone receptor-positive, HER2-negative metastatic breast cancer
- Measurable or evaluable disease by RECIST v1.1
- Candidate for capecitabine treatment as decided by physician
- No more than one prior chemotherapy for metastatic disease
- Prior endocrine therapy with CDK4/6 inhibitor
- On denosumab or zoledronic acid for at least 6 months if used prior to enrollment, with a 3-week washout before treatment
- At least 18 years old
- ECOG performance status 0, 1, or 2
- Life expectancy of at least 12 weeks
- Adequate bone marrow and organ function including leukocytes 3 K/cumm, ANC 1.5 K/cumm, platelets 100 K/cumm, total bilirubin 1.5 x IULN (or 3 mg/dL with Gilbert Syndrome), AST/ALT 3.0 x IULN, creatinine clearance > 60 mL/min, normal calcium
- Women of childbearing potential and heterosexually active men must agree to use contraception during and after treatment
- Ability to understand and sign informed consent
- Archival tissue sample available or PI approval if unavailable
- (Phase Ib) Bone metastasis not required
- (Phase Ib) Candidate for or on stable doses of capecitabine (1000 mg/m^2 BID, 14 days on, 7 days off) with no more than grade 1 adverse events related to capecitabine
- (Phase II) Progressive bone metastasis or clinical progression per physician
You will not qualify if you...
- Radiation therapy within 1 week prior to treatment
- Systemic chemotherapy within 3 weeks prior to treatment
- Immunotherapy within 3 weeks prior to treatment
- Oral chemotherapy or targeted therapy within 5 half-lives prior to treatment
- Use of strong/moderate CYP3A4 and CYP2C8 inhibitors or inducers, or QT prolonging drugs within 5 half-lives prior to treatment
- Untreated brain metastases; treated brain metastases must be stable and off steroids
- Allergic reactions to similar compounds to study drugs
- History of acute or untreated skeletal related events or changes in anti-resorptive therapy
- Uncontrolled illnesses including infections, congestive heart failure, unstable angina, or arrhythmia
- Pregnant or breastfeeding; women must have negative pregnancy test within 14 days prior to treatment
- HIV patients with CD4+ counts < 350 cells/mcL or recent AIDS-defining infections
- Screening resting QTcF above 470 msec
- (Phase Ib) Capecitabine taken within 2 weeks prior to treatment
- (Phase II) Prior capecitabine in metastatic setting
- (Phase II) History of other malignancy unless treated and disease-free for at least 2 years
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
The University of Kansas Cancer Center
Westwood, Kansas, United States, 66205
Actively Recruiting
2
Mayo Clinic
Rochester, Minnesota, United States, 55905
Not Yet Recruiting
3
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
Research Team
C
Cynthia X Ma, M.D., Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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