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

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

152

Participants

Timeline

Start Date

January 30, 2025

Primary Completion Date

May 31, 2032

Study Completion Date

May 31, 2032

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.

Trial Locations (3)

55905

NOT_YET_RECRUITING

Mayo Clinic, Rochester

63110

RECRUITING

Washington University School of Medicine, St Louis

66205

NOT_YET_RECRUITING

The University of Kansas Cancer Center, Westwood

Sponsors
All Listed Sponsors
collaborator

United States Department of Defense

FED

collaborator

Aclaris Therapeutics, Inc.

INDUSTRY

lead

Washington University School of Medicine

OTHER

NCT06374459 - Zunsemetinib in Combination With Capecitabine in Patients With Hormone Receptor-Positive and HER2-Negative Metastatic Breast Cancer With Bone Metastasis | Biotech Hunter | Biotech Hunter