Last updated 4 months ago
A Study of Samuraciclib in Combination With Fulvestrant in Metastatic or Locally Advanced Breast Cancer in Adult Participants
60 patients around the world
Available in Spain, United States, Mexico
Carrick Therapeutics Limited
4Research sites
60Patients around the world
This study is for people with
Breast Cancer
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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.
- 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
Centro de Investigación Clínica de Oaxaca - Oaxaca
Recruiting
Cryptex Investigación Clínica
Recruiting
SOLTMED SMO
Recruiting
Actualidad Basada en la Investigación del Cáncer
Recruiting
StudySUMIT-BC
SponsorCarrick Therapeutics Limited
Conditions
Breast Cancer
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05963984
