A Study of Samuraciclib and Elacestrant in Participants With Metastatic or Locally Advanced HR+/HER2-negative Breast Cancer (SUMIT-ELA)
Metastatic Breast Cancer, Locally Advanced Breast Cancer, Breast Cancer
About this trial
This is an interventional treatment trial for Metastatic Breast Cancer focused on measuring Metastatic Breast Cancer, Advanced Breast Cancer, Breast Cancer, HR Positive, HER2-Negative
Eligibility Criteria
Inclusion Criteria: Histologically confirmed diagnosis of ER-positive, HER2-negative locally advanced or metastatic breast cancer. Documented objective disease progression while on or within 6 months after the end of 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 by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Pre/peri-menopausal participants must have commenced treatment with a luteinizing hormone-releasing hormone (LHRH) agonist at least 4 weeks prior to first dose of study intervention. Eastern Cooperative Oncology Group (ECOG) performance status ≤1 with no deterioration over the past 2 weeks. Expected life expectancy of >12 weeks in the judgement of the treating investigator. 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 carcinoma in situ of the cervix. More than 1 line of endocrine treatment for locally advanced or metastatic disease treatment. Inadequate hepatic, renal, and bone marrow function. Clinically significant cardiovascular disease. Any current or prior central nervous system metastases, carcinomatous meningitis, or leptomeningeal disease. Pregnant or breastfeeding women.
Sites / Locations
- Site 43 - Mid Florida Hematology and Oncology CenterRecruiting
- Site 38 - Northwestern University, Feinberg School of Medicine, Northwestern University
- Site 40 - Massachusetts General Hospital
- Site 42 - Dana-Farber Cancer Institute, EDDC
- Site 35 - Cleveland Clinic, Taussig Cancer Institute
- Site 34 -The University of Texas, MD Anderson Cancer Center, Nellie B. Connally Breast Center
- Site 41 - The START Center for Cancer Care, South Texas Oncology and HematologyRecruiting
- Site 32 - Swedish Medical Center, Swedish Cancer Institute (SCI),Cherry Hill Campus
- Site 81 - Bergonie unicancer, Nouvelle-Aquitaine, L'Institut Bergonie
- Site 80 - Centre Jean Bernard, Clinique Victor Hugo
- Site 84 - UNICANCER, Centre Leon-Berard (CLB)
- Site 83 - Institut Paoli Calmettes (IPC)
- Site 85 - Institut Curie
- Site 82 - Institut de Cancerologie de Ouest (ICO)
- Site 65 - Complexo Hospitalario Universitario A CoruñaRecruiting
- Site 64 - Hospital Clinic de Barcelona (Hospital Clinic i Provincial)Recruiting
- Site 68 -Hospital Universitario Vall d'Hebron
- Site 61 - Institut Catala d'Oncologia (ICO), Hospital Duran i Reynals Location
- Site 62 - Universidad de Navarra, Clinica Universidad de Navarra (CUN)Recruiting
- Site 63 - South Texas Accelerated Research Therapeutics, CIOCC, Hospital Madrid Norte-Sanchinarro
- Site 66 - Hospital Clinico San Carlos
- Site 69 - Universidad de Navarra - Clinica Universidad de Navarra (CUN)
- Site 60 - NEXT Oncology EU Hospital Universitario Quiron Salud Madrid
- Site 67 - Universidad de Sevilla, Hospital Universitario Virgen Macarena
- Site 12 - Belfast City Hospital
- Site 4 - The Christie NHS Foundation Trust
- Site 13 - Nottingham City Hospital
- Site 2 - Oxford University Hospitals NHS Trust - Churchill Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
Cohort 1
Cohort 2
Cohort 3
Cohort 4 Expansion
Up to 6 evaluable participants will receive samuraciclib 240 mg in combination with elacestrant 300 mg in cycles of 28 days (Cycle 1 to 6), 56 days (Cycle 7 to 9) and up to 84 days (Cycles 10 onwards).
Up to 6 evaluable participants will receive samuraciclib in combination with elacestrant at the SRC recommended dose (anticipated 360mg samuraciclib, 300 mg elacestrant) in cycles of 28 days (Cycle 1 to 6), 56 days (Cycle 7 to 9) and up to 84 days (Cycles 10 onward).
Up to 6 evaluable participants will receive samuraciclib in combination with elacestrant at the SRC recommended dose (anticipated 360mg samuraciclib, 400 mg elacestrant) in cycles of 28 days (Cycle 1 to 6), 56 days (Cycle 7 to 9) and up to 84 days (Cycles 10 onward).
Up to 30 evaluable participants will receive samuraciclib in combination with elacestrant at the SRC recommended dose (anticipated 360mg samuraciclib, 400 mg elacestrant) in cycles of 28 days (Cycle 1 to 6), 56 days (Cycle 7 to 9) and up to 84 days (Cycles 10 onward).