Spots Global Cancer Trial Database for A Study of Samuraciclib and Elacestrant in Participants With Metastatic or Locally Advanced HR+/HER2-negative Breast Cancer
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Trial Identification
Brief Title: A Study of Samuraciclib and Elacestrant in Participants With Metastatic or Locally Advanced HR+/HER2-negative Breast Cancer
Official Title: A Phase 1b/2 Open-label Study of Samuraciclib in Combination With Elacestrant in Participants With Metastatic or Locally Advanced Hormone Receptor-positive and Human Epidermal Growth Factor Receptor 2-negative Breast Cancer
Study ID: NCT05963997
Study Description
Brief Summary: This is an international, multisite, open-label, Phase 1b/2 study, to confirm safety and efficacy of samuraciclib in combination with elacestrant in adult participants with metastatic or locally advanced Hormone Receptor (HR) positive and Human Epidermal Growth Factor Receptor (HER)2-negative breast cancer.
Detailed Description: This is a multiple cohort study, an initial dose escalation phase is designed to confirm the safe dose of samuraciclib in combination with elacestrant. A Safety Review Committee (SRC) will monitor the safety, tolerability, and PK data during this phase. Once ascertained, an expansion cohort will be opened to explore the efficacy of samuraciclib in combination with elacestrant.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Site 43 - Mid Florida Hematology and Oncology Center, Orange City, Florida, United States
Site 38 - Northwestern University, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, United States
Site 40 - Massachusetts General Hospital, Boston, Massachusetts, United States
Site 42 - Dana-Farber Cancer Institute, EDDC, Boston, Massachusetts, United States
Site 35 - Cleveland Clinic, Taussig Cancer Institute, Cleveland, Ohio, United States
Site 41 - The START Center for Cancer Care, South Texas Oncology and Hematology, San Antonio, Texas, United States
Site 32 - Swedish Medical Center, Swedish Cancer Institute (SCI),Cherry Hill Campus, Seattle, Washington, United States
Site 81 - Bergonie unicancer, Nouvelle-Aquitaine, L'Institut Bergonie, Bordeaux, , France
Site 80 - Centre Jean Bernard, Clinique Victor Hugo, Le Mans, , France
Site 84 - UNICANCER, Centre Leon-Berard (CLB), Lyon, , France
Site 83 - Institut Paoli Calmettes (IPC), Marseille, , France
Site 85 - Institut Curie, Paris, , France
Site 82 - Institut de Cancerologie de Ouest (ICO), Saint-Herblain, , France
Site 65 - Complexo Hospitalario Universitario A Coruña, A Coruña, , Spain
Site 64 - Hospital Clinic de Barcelona (Hospital Clinic i Provincial), Barcelona, , Spain
Site 68 -Hospital Universitario Vall d'Hebron, Barcelona, , Spain
Site 61 - Institut Catala d'Oncologia (ICO), Hospital Duran i Reynals Location, L'Hospitalet De Llobregat, , Spain
Site 62 - Universidad de Navarra, Clinica Universidad de Navarra (CUN), Madrid, , Spain
Site 63 - South Texas Accelerated Research Therapeutics, CIOCC, Hospital Madrid Norte-Sanchinarro, Madrid, , Spain
Site 66 - Hospital Clinico San Carlos, Madrid, , Spain
Site 69 - Universidad de Navarra - Clinica Universidad de Navarra (CUN), Pamplona, , Spain
Site 60 - NEXT Oncology EU Hospital Universitario Quiron Salud Madrid, Pozuelo de Alarcon, , Spain
Site 67 - Universidad de Sevilla, Hospital Universitario Virgen Macarena, Sevilla, , Spain
Site 12 - Belfast City Hospital, Belfast, , United Kingdom
Site 4 - The Christie NHS Foundation Trust, Manchester, , United Kingdom
Site 13 - Nottingham City Hospital, Nottingham, , United Kingdom
Site 2 - Oxford University Hospitals NHS Trust - Churchill Hospital, Oxford, , United Kingdom
Contact Details
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