A Study of Samuraciclib in Combination With Fulvestrant in Metastatic or Locally Advanced Breast Cancer in Adult Participants
NCT ID: NCT05963984
Last Updated: 2025-12-26
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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COMPLETED
PHASE2
60 participants
INTERVENTIONAL
2023-11-16
2025-08-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A
Participants will receive 360 mg of samuraciclib on cycles of 28 days (Cycle 1 to 6), 56 days (Cycle 7 to 9) and up to 84 days (Cycles 10 onwards in combination with fulvestrant administered monthly, plus an additional dose at Cycle 1 Day 15.
Samuraciclib
Samuraciclib tablet by mouth once a day
Fulvestrant
Injection administered monthly (i.e., every 4 weeks), plus additional dose at Cycle 1 Day 15
Arm B
Participants will receive 240 mg of samuraciclib on cycles of 28 days (Cycle 1 to 6), 56 days (Cycle 7 to 9) and up to 84 days (Cycles 10 onwards in combination with fulvestrant administered monthly, plus an additional dose at Cycle 1 Day 15.
Samuraciclib
Samuraciclib tablet by mouth once a day
Fulvestrant
Injection administered monthly (i.e., every 4 weeks), plus additional dose at Cycle 1 Day 15
Arm C
Participants will receive fulvestrant administered monthly, plus additional dose at Cycle 1 Day 15.
Fulvestrant
Injection administered monthly (i.e., every 4 weeks), plus additional dose at Cycle 1 Day 15
Interventions
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Samuraciclib
Samuraciclib tablet by mouth once a day
Fulvestrant
Injection administered monthly (i.e., every 4 weeks), plus additional dose at Cycle 1 Day 15
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 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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Pfizer
INDUSTRY
Carrick Therapeutics Limited
INDUSTRY
Responsible Party
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Locations
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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
The Center for Cancer and Blood Disorders
Fort Worth, Texas, United States
Szent Borbala Korhaz
Tatabánya, Komárom-Esztergom, Hungary
Nograd Varmegyei Szent Lazar Korhaz
Salgótarján, Nógrád megye, Hungary
Semmelweis Egyetem
Budapest, , Hungary
Actualidad Basada en la Investigación del Cáncer
Guadalajara, Jalisco, Mexico
Renati Innovation S.A.P.I de C.V
Guadalajara, Jalisco, Mexico
Soltmed SMO
Mexico City, Mexico City, Mexico
Cryptex Investigación Clínica S.A. de C.V.
Cuauhtémoc, , Mexico
Oaxaca Site Management Organization S.C.
Oaxaca City, , Mexico
Centro de Investigacion Clinica de Oaxaca
Oaxaca City, , Mexico
Institut Català d'Oncologia - L'Hospitalet
L'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
Gulhane Egitim ve Arastirma Hastanesi
Ankara, , Turkey (Türkiye)
Gazi University
Ankara, , Turkey (Türkiye)
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastırma Hastanesi
Ankara, , Turkey (Türkiye)
Hacettepe Universite Hastaneleri
Ankara, , Turkey (Türkiye)
Trakya University
Edirne, , Turkey (Türkiye)
Istanbul Universitesi Istanbul Tıp Fakultesi Hastanesi
Istanbul, , Turkey (Türkiye)
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi
Istanbul, , Turkey (Türkiye)
I.E.U. Medical Point Hastanesi
Izmir, , Turkey (Türkiye)
Countries
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Other Identifiers
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2023-503903-27-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
Z0041001
Identifier Type: OTHER
Identifier Source: secondary_id
CT7001_002
Identifier Type: -
Identifier Source: org_study_id