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Brief Title: A Study of Samuraciclib in Combination With Fulvestrant in Metastatic or Locally Advanced Breast Cancer in Adult Participants
Official Title: An Open-label, Interventional, Multicenter, Randomized, Phase 2 Study of Fulvestrant With or Without Samuraciclib in Participants With Metastatic or Locally Advanced Hormone Receptor (HR) Positive and Human Epidermal Growth Factor Receptor (HER)2-Negative Breast Cancer (BC)
Study ID: NCT05963984
Brief Summary: The purpose of this study is to evaluate the safety and efficacy of samuraciclib in combination with fulvestrant versus fulvestrant alone 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:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Ocala Oncology Center PL DBA Florida Cancer Affiliates, Ocala, Florida, United States
Mfsmc-Hjwci, Baltimore, Maryland, United States
Saint Luke's Cancer Institute, Kansas City, Missouri, United States
Sidney Kimmel Cancer Center - Jefferson Health, Philadelphia, Pennsylvania, United States
Nograd Varmegyei Szent Lazar Korhaz, Salgótarján, Nógrád, Hungary
Institut Català d'Oncologia - L'Hospitalet, Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Marqués de Valdecilla, Santander, Cantabria Comunidad De, Spain
Hospital Clinico San Carlos, Madrid, Madrid, Comunidad De, Spain
Hospital Infanta Cristina, Badajoz, , Spain
Parc de Salut Mar - Hospital del Mar, Barcelona, , Spain
Hospital Universitari Vall d'Hebron, Barcelona, , Spain
MD Anderson Cancer Center, Madrid, , Spain
Hospital Vithas Málaga, Málaga, , Spain
Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca, Salamanca, , Spain
Hospital Clinico de Valencia, Valencia, , Spain
Gazi University, Ankara, , Turkey
Hacettepe Universite Hastaneleri, Ankara, , Turkey
Trakya University, Edirne, , Turkey
Istanbul Universitesi Istanbul Tıp Fakultesi Hastanesi, Istanbul, , Turkey
I.E.U. Medical Point Hastanesi, İzmir, , Turkey