A Study of Samuraciclib and Elacestrant in Participants With Metastatic or Locally Advanced HR+/HER2-negative Breast Cancer
NCT ID: NCT05963997
Last Updated: 2026-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1/PHASE2
49 participants
INTERVENTIONAL
2023-10-09
2026-02-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Cohort 1
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).
Samuraciclib
Samuraciclib capsules by mouth once a day
Elacestrant Dihydrochloride
Elacestrant tablets by mouth once a day
Cohort 2
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).
Samuraciclib
Samuraciclib capsules by mouth once a day
Elacestrant Dihydrochloride
Elacestrant tablets by mouth once a day
Cohort 3
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).
Samuraciclib
Samuraciclib capsules by mouth once a day
Elacestrant Dihydrochloride
Elacestrant tablets by mouth once a day
Cohort 4 Expansion
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).
Samuraciclib
Samuraciclib capsules by mouth once a day
Elacestrant Dihydrochloride
Elacestrant tablets by mouth once a day
Interventions
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Samuraciclib
Samuraciclib capsules by mouth once a day
Elacestrant Dihydrochloride
Elacestrant tablets by mouth once a day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Berlin-Chemie AG Menarini Group
INDUSTRY
Carrick Therapeutics Limited
INDUSTRY
Responsible Party
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Locations
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Site 38 - Northwestern University, Feinberg School of Medicine, Northwestern University
Chicago, Illinois, 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 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 Alarcón, , Spain
Site 67 - Universidad de Sevilla, Hospital Universitario Virgen Macarena
Seville, , Spain
Site 12 - Belfast City Hospital
Belfast, , United Kingdom
Site 4 - The Christie NHS Foundation Trust
Manchester, , United Kingdom
Site 2 - Oxford University Hospitals NHS Trust - Churchill Hospital
Oxford, , United Kingdom
Countries
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Other Identifiers
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2023-503846-30-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
2023-000072-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CT7001_003
Identifier Type: -
Identifier Source: org_study_id
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