Clinical Research Directory

ESR1 Mutations in Metastatic Hormone Receptor-Positive Breast Cancer in the Greek Population

The goal of this observational study is to assess the prevalence of ESR1 mutations in patients with metastatic hormone receptor-positive/HER2-negative breast cancer in Greece and evaluate the associations of these mutations with disease characteristics, clinical outcomes and real-world treatment patterns. This study will include participants who have already undergone ESR1 testing as part of their standard medical care. Patient real-world data will be extracted by the patient's medical records. No additional procedures or visits beyond routine care will be required. Data will be collected from routine clinical visits and standard-of-care treatment.

Organ Culture for Endocrine Resistant Next Line: A Treatment Selection Study in Metastatic Breast Cancer

This study evaluates whether testing fresh tumor samples outside the body can help guide treatment selection for patients with hormone receptor-positive, HER2-negative metastatic breast cancer that has progressed during endocrine therapy. A biopsy sample from each participant will be tested using an ex vivo organ culture (EVOC) platform, which preserves the tumor tissue and allows researchers to assess its response to different anticancer treatments. The results will be used to help select the participant's next systemic treatment. The main objective is to evaluate the proportion of patients whose cancer responds to treatment selected using this approach. The study will also assess how long the cancer remains controlled, overall survival, and the relationship between laboratory test results and clinical outcomes.

Efficacy and Safety of Camizestrant Plus Ribociclib in Patients With Breast Cancer

This trial will study a type of breast cancer defined by the expression of hormone receptor in the cancer cells (HR+). Patients will be treated with ribociclib, a cyclin-dependent kinase inhibitor, and camizestrant, a selective estrogen receptor degrader (SERD) and complete ER antagonist. The main purpose of the Study is to analyze the efficacy (to find out how effective a treatment is) of ribociclib in combination with camizestrant in patients with advanced HR+ breast cancer who have received endocrine therapy (ET) in early breast cancer setting for at least 5 years, of which at least 2 years with aromatase inhibitor (AI). Ribociclib plus camizestrant efficacy will be determined by assessing the period from treatment initiation until disease progression, defined as progression free survival (PFS). The anticipated favorable clinical benefits of the combination of ribociclib and camizestrant therapy are projected to outweigh the risks of this treatment. This Study will be performed in full compliance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and all applicable local Good Clinical Practice (GCP) and regulations.