protocolSection identificationModule nctId: NCT06374459, orgStudyIdInfo id: 24-x109, secondaryIdInfos id: BC200714, type: OTHER_GRANT, domain: Department of Defense, briefTitle: Zunsemetinib in Combination With Capecitabine in Patients With Hormone Receptor-Positive and HER2-Negative Metastatic Breast Cancer With Bone Metastasis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-31, primaryCompletionDateStruct date: 2031-11-30, completionDateStruct date: 2031-11-30, studyFirstPostDateStruct date: 2024-04-18, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Washington University School of Medicine, class: OTHER, collaborators name: United States Department of Defense, collaborators name: Aclaris Therapeutics, Inc., descriptionModule briefSummary: 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)., conditionsModule conditions: Hormone Receptor Positive HER-2 Negative Metastatic Breast Cancer, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: The Phase I portion of the study is sequential and patients will not be randomized and the Phase II portion is parallel and patients will be randomized., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 138, type: ESTIMATED, armsInterventionsModule interventions name: Zumsemetinib, interventions name: Capecitabine, interventions name: Zoledronic acid, interventions name: Denosumab, outcomesModule primaryOutcomes measure: Number of participants with adverse events (Phase Ib only), primaryOutcomes measure: Recommended phase II dose of zunsemetinib (Phase Ib only), primaryOutcomes measure: Percent change in serum CTX (Phase II only), primaryOutcomes measure: Progression-free survival (PFS) (Phase II only), secondaryOutcomes measure: Treatment-induced changes in DEXA BMD (g/cm^2) at hip and spine (Phase Ib only), secondaryOutcomes measure: Treatment-induced changes in sCTX by clinical assay (Phase II only), secondaryOutcomes measure: Objective response rate (ORR) (Phase II only), secondaryOutcomes measure: Clinical benefit rate (Phase II only), secondaryOutcomes measure: Overall survival (OS) (Phase II only), secondaryOutcomes measure: Treatment-induced changes in DEXA BMD (g/cm^2) at hip and spine (Phase II only), secondaryOutcomes measure: Treatment-induced changes in quality of life as measured by EORTC QLQ-C30 (Phase II only), secondaryOutcomes measure: Treatment-induced changes in pain as measured by Brief Pain Inventory (BPI) (Phase II only), secondaryOutcomes measure: Number of participants with adverse events (Phase II only), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The University of Kansas Cancer Center, city: Westwood, state: Kansas, zip: 66205, country: United States, contacts name: Qamar Khan, M.D., role: CONTACT, phone: 913-588-1227, contacts name: Qamar Khan, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.04056, lon: -94.6169, locations facility: Mayo Clinic, city: Rochester, state: Minnesota, zip: 55905, country: United States, contacts name: Matthew Goetz, M.D., role: CONTACT, phone: 507-284-2511, email: Goetz.Matthew@mayo.edu, contacts name: Matthew Goetz, M.D., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.02163, lon: -92.4699, locations facility: Washington University School of Medicine, city: Saint Louis, state: Missouri, zip: 63110, country: United States, contacts name: Cynthia X Ma, M.D., Ph.D., role: CONTACT, phone: 314-362-8903, email: cynthiaxma@wustl.edu, contacts name: Cynthia X Ma, M.D., Ph.D., role: PRINCIPAL_INVESTIGATOR, contacts name: Sheila Stewart, Ph.D., role: SUB_INVESTIGATOR, contacts name: Roberto Civitelli, M.D., role: SUB_INVESTIGATOR, contacts name: Jingqin (Rosy) Luo, Ph.D., role: SUB_INVESTIGATOR, contacts name: Foluso Ademuyiwa, M.D., role: SUB_INVESTIGATOR, contacts name: Nusayba Bagegni, M.D., role: SUB_INVESTIGATOR, contacts name: Ron Bose, M.D., Ph.D., role: SUB_INVESTIGATOR, contacts name: Andrew Davis, M.D., role: SUB_INVESTIGATOR, contacts name: Ashley Frith, M.D., Ph.D., role: SUB_INVESTIGATOR, contacts name: Faisal Fa'ak, M.D., role: SUB_INVESTIGATOR, contacts name: Lindsay Peterson, M.D., role: SUB_INVESTIGATOR, contacts name: Rama Suresh, M.D., role: SUB_INVESTIGATOR, geoPoint lat: 38.62727, lon: -90.19789, hasResults: False