A Prospective Observational Study to Describe Clinical Outcomes, Treatment Patterns, Patients Characteristics Among Patients With HR+/HER2- Advanced BC Initiating Treatment With Risarg®, Piqray®, Endocrine Therapy or Chemotherapy in Routine Clinical Practice in Russia
brief summary
This study was planned as a prospective multicenter NIS. This study was observational in nature and did not impose a therapy protocol, diagnostic/therapeutic interventions or a visit schedule. Patients with HR+/ HER2- advanced or metastatic BC that initiated treatment with ribociclib, alpelisib, mono endocrine therapy or chemotherapy were included in the study across seven Russian districts.
detailed description
Patients attended the sites in accordance with routine clinical practice. It was assumed that visits would be conducted every 3-4 months. Patients underwent standard procedures and tests according to clinical guidelines and physician's judgement. Available data from routine clinical management of the patients was collected at patients' visits to the clinical site. Patients enrolled in the study were followed up until death or study close whichever occurred first. The recruitment period was planned for 24 months, observation period for maximum of 24 months, with total duration of study 4 years. Patients could discontinue from this NIS at any time.
official title
A Prospective Observational Study to Describe Clinical Outcomes, Treatment Patterns, Patients Characteristics Among Patients With HR+/HER2- Advanced BC Initiating Treatment With Risarg® (Ribociclib), Piqray® (Alpelisib), Endocrine Therapy or Chemotherapy in Routine Clinical Practice in Russia