Phase
Condition
Breast Cancer
Cancer
Metastatic Cancer
Treatment
Samuraciclib
Elacestrant Dihydrochloride
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Histologically confirmed diagnosis of ER-positive, HER2-negative locally advanced ormetastatic breast cancer.
Documented objective disease progression while on or within 6 months after the endof the most recent therapy.
Received prior AI in combination with a CDK4/6i as the last therapy
Known TP53 and ESR1 mutation status.
Participants must have measurable disease or bone only disease as defined byResponse Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
Pre/peri-menopausal participants must have commenced treatment with a luteinizinghormone-releasing hormone (LHRH) agonist at least 4 weeks prior to first dose ofstudy intervention.
Eastern Cooperative Oncology Group (ECOG) performance status ≤1 with nodeterioration over the past 2 weeks.
Expected life expectancy of >12 weeks in the judgement of the treating investigator.
Exclusion
Exclusion Criteria:
Inflammatory breast cancer.
Participants with any other active malignancy within 3 years prior to enrollment,except for adequately treated basal cell or squamous cell skin cancer, or carcinomain situ of the cervix.
More than 1 line of endocrine treatment for locally advanced or metastatic diseasetreatment.
Inadequate hepatic, renal, and bone marrow function.
Clinically significant cardiovascular disease.
Any current or prior central nervous system metastases, carcinomatous meningitis, orleptomeningeal disease.
Pregnant or breastfeeding women.
Study Design
Study Description
Connect with a study center
Site 81 - Bergonie unicancer, Nouvelle-Aquitaine, L'Institut Bergonie
Bordeaux,
FranceSite Not Available
Site 80 - Centre Jean Bernard, Clinique Victor Hugo
Le Mans,
FranceSite Not Available
Site 84 - UNICANCER, Centre Leon-Berard (CLB)
Lyon,
FranceSite Not Available
Site 83 - Institut Paoli Calmettes (IPC)
Marseille,
FranceSite Not Available
Site 85 - Institut Curie
Paris,
FranceSite Not Available
Site 82 - Institut de Cancerologie de Ouest (ICO)
Saint-Herblain,
FranceSite Not Available
Site 65 - Complexo Hospitalario Universitario A Coruña
A Coruña,
SpainSite Not Available
Site 64 - Hospital Clinic de Barcelona (Hospital Clinic i Provincial)
Barcelona,
SpainSite Not Available
Site 68 -Hospital Universitario Vall d'Hebron
Barcelona,
SpainSite Not Available
Site 61 - Institut Catala d'Oncologia (ICO), Hospital Duran i Reynals Location
L'Hospitalet De Llobregat,
SpainSite Not Available
Site 62 - Universidad de Navarra, Clinica Universidad de Navarra (CUN)
Madrid,
SpainSite Not Available
Site 63 - South Texas Accelerated Research Therapeutics, CIOCC, Hospital Madrid Norte-Sanchinarro
Madrid,
SpainSite Not Available
Site 66 - Hospital Clinico San Carlos
Madrid,
SpainSite Not Available
Site 69 - Universidad de Navarra - Clinica Universidad de Navarra (CUN)
Pamplona,
SpainSite Not Available
Site 60 - NEXT Oncology EU Hospital Universitario Quiron Salud Madrid
Pozuelo de Alarcon,
SpainSite Not Available
Site 67 - Universidad de Sevilla, Hospital Universitario Virgen Macarena
Sevilla,
SpainSite Not Available
Site 12 - Belfast City Hospital
Belfast,
United KingdomSite Not Available
Site 4 - The Christie NHS Foundation Trust
Manchester,
United KingdomSite Not Available
Site 13 - Nottingham City Hospital
Nottingham,
United KingdomSite Not Available
Site 2 - Oxford University Hospitals NHS Trust - Churchill Hospital
Oxford, OX3 7LE
United KingdomSite Not Available
Site 43 - Mid Florida Hematology and Oncology Center
Orange City, Florida 32763
United StatesSite Not Available
Site 38 - Northwestern University, Feinberg School of Medicine, Northwestern University
Chicago, Illinois 60611
United StatesSite Not Available
Site 40 - Massachusetts General Hospital
Boston, Massachusetts 02114-2696
United StatesSite Not Available
Site 42 - Dana-Farber Cancer Institute, EDDC
Boston, Massachusetts 02215
United StatesSite Not Available
Site 35 - Cleveland Clinic, Taussig Cancer Institute
Cleveland, Ohio 44106
United StatesSite Not Available
Site 34 -The University of Texas, MD Anderson Cancer Center, Nellie B. Connally Breast Center
Houston, Texas 77030
United StatesSite Not Available
Site 41 - The START Center for Cancer Care, South Texas Oncology and Hematology
San Antonio, Texas 78229
United StatesSite Not Available
Site 32 - Swedish Medical Center, Swedish Cancer Institute (SCI),Cherry Hill Campus
Seattle, Washington 98122
United StatesSite Not Available
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