Study on Outcomes of First-Line CDK46 Inhibitors with Endocrine Therapy in Advanced HR HER2- Breast Cancer Patients in Italy

What this Trial Is About

Researchers are investigating advanced breast cancer that is hormone receptor-positive and HER2-negative, focusing on patients receiving first-line treatment with CDK46 inhibitors combined with endocrine therapy. The study is observational and multicenter, aiming to gather real-world evidence from clinical data, medical imaging, and biological samples. The study includes various sub-studies that address different aspects of treatment outcomes and patient responses. The study involves collecting data from five sub-studies real-world clinical data comparing survival outcomes among patients treated with three CDK46 inhibitors safety data on comorbidities, medications, and toxicities medical imaging analyses using CT and PET scans genomic and transcriptomic analyses from tumor samples and evaluation of treatment patterns after progression on first-line therapy. These sub-studies use different methods for data collection, extraction, and analysis to build predictive models to assist treatment decisions. Participants will have their medical records reviewed for clinical outcomes, imaging studies collected and analyzed, and biological samples obtained for molecular testing. Researchers will assess overall survival up to 120 months from treatment start, along with progression-free survival and time to subsequent treatments. The study tracks severe toxicities and gathers detailed comorbidity information to understand treatment safety. Participant involvement is based on data collection rather than active treatment assignment, with the study continuing through various follow-up periods to monitor long-term outcomes.

Predicting clinicAL outcoMes During First-line CDK4/6 Inhibitors Plus Endocrine Therapy in Patients With Advanced Hormone REceptor-poSitive HER2-negative Breast Cancer: the Retrospective-prospective Multicenter Italian PALMARES-2 Study