nctId: NCT06374459 id: 24-x109 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 overallStatus: NOT_YET_RECRUITING date: 2024-07-31 date: 2031-11-30 date: 2031-11-30 date: 2024-04-18 date: 2024-04-18 name: Washington University School of Medicine class: OTHER name: United States Department of Defense name: Aclaris Therapeutics, Inc. 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). conditions: Hormone Receptor Positive HER-2 Negative Metastatic Breast Cancer studyType: INTERVENTIONAL phases: PHASE1 phases: PHASE2 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 masking: NONE count: 138 type: ESTIMATED name: Zumsemetinib name: Capecitabine name: Zoledronic acid name: Denosumab measure: Number of participants with adverse events (Phase Ib only) measure: Recommended phase II dose of zunsemetinib (Phase Ib only) measure: Percent change in serum CTX (Phase II only) measure: Progression-free survival (PFS) (Phase II only) measure: Treatment-induced changes in DEXA BMD (g/cm^2) at hip and spine (Phase Ib only) measure: Treatment-induced changes in sCTX by clinical assay (Phase II only) measure: Objective response rate (ORR) (Phase II only) measure: Clinical benefit rate (Phase II only) measure: Overall survival (OS) (Phase II only) measure: Treatment-induced changes in DEXA BMD (g/cm^2) at hip and spine (Phase II only) measure: Treatment-induced changes in quality of life as measured by EORTC QLQ-C30 (Phase II only) measure: Treatment-induced changes in pain as measured by Brief Pain Inventory (BPI) (Phase II only) measure: Number of participants with adverse events (Phase II only) sex: ALL minimumAge: 18 Years stdAges: ADULT stdAges: OLDER_ADULT facility: The University of Kansas Cancer Center city: Westwood state: Kansas zip: 66205 country: United States name: Qamar Khan, M.D. role: CONTACT phone: 913-588-1227 name: Qamar Khan, M.D. role: PRINCIPAL_INVESTIGATOR lat: 39.04056 lon: -94.6169 facility: Mayo Clinic city: Rochester state: Minnesota zip: 55905 country: United States name: Matthew Goetz, M.D. role: CONTACT phone: 507-284-2511 email: Goetz.Matthew@mayo.edu name: Matthew Goetz, M.D. role: PRINCIPAL_INVESTIGATOR lat: 44.02163 lon: -92.4699 facility: Washington University School of Medicine city: Saint Louis state: Missouri zip: 63110 country: United States name: Cynthia X Ma, M.D., Ph.D. role: CONTACT phone: 314-362-8903 email: cynthiaxma@wustl.edu name: Cynthia X Ma, M.D., Ph.D. role: PRINCIPAL_INVESTIGATOR name: Sheila Stewart, Ph.D. role: SUB_INVESTIGATOR name: Roberto Civitelli, M.D. role: SUB_INVESTIGATOR name: Jingqin (Rosy) Luo, Ph.D. role: SUB_INVESTIGATOR name: Foluso Ademuyiwa, M.D. role: SUB_INVESTIGATOR name: Nusayba Bagegni, M.D. role: SUB_INVESTIGATOR name: Ron Bose, M.D., Ph.D. role: SUB_INVESTIGATOR name: Andrew Davis, M.D. role: SUB_INVESTIGATOR name: Ashley Frith, M.D., Ph.D. role: SUB_INVESTIGATOR name: Faisal Fa'ak, M.D. role: SUB_INVESTIGATOR name: Lindsay Peterson, M.D. role: SUB_INVESTIGATOR name: Rama Suresh, M.D. role: SUB_INVESTIGATOR lat: 38.62727 lon: -90.19789 hasResults: False