A Study of Samuraciclib in Combination With Fulvestrant in Metastatic or Locally Advanced Breast Cancer in Adult Participants
Completed · Phase 2
Conditions studied: Metastatic Breast Cancer, Locally Advanced Breast Cancer, Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT05963984
- Run by
- Carrick Therapeutics Limited
- People needed
- 60
- Starts
- 2023-11-16
- Expected to finish
- 2025-08-28
- Last updated by the study team
- 2025-12-26
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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 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.
You may not qualify if…
- 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.
Where it is running
- 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)
Full record on ClinicalTrials.gov
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