Exploration of breast cancer biology for the development of diagnostic tools and individualized treatments –a prospective and longitudinal study

Abstract Introduction Despite improvements in survival, 20–30% of patients with early breast cancer still die from metastatic disease. New technologies offer opportunities to investigate the metastatic process at the molecular level and to elucidate the molecular basis of different patterns of disease progression during treatment. This will require the design of high-quality clinical studies with biological sample collection for appropriate analyses. This study aims to design a population-based, healthcare-integrated clinical study that could facilitate the integration of new technologies into clinical practice. Method Through this prospective longitudinal study, biological samples, along with information on patient-, tumor-, and treatment-related characteristics, will be collected. All breast cancer patients over 18 years of age at Örebro University Hospital will be eligible for inclusion. Tissue samples will be obtained from the primary tumor during surgical removal, from any affected lymph nodes, and from metastatic site. Blood samples will be collected at baseline, throughout follow-up, and at the time of disease recurrence. Patient-, tumor-, and treatment-related characteristics will be continuously collected through the register Individuell patientöversikt. For the analysis of biological samples, sequencing methods and other large-scale techniques such as microarray, mass spectrometry, and Olink proteomics will be used. Result The results may contribute to the clinical implementation of additional predictive or prognostic biomarkers, as well as to the development of new de-escalation or escalation strategies. Biomarkers for earlier detection of disease recurrence and for identifying increased risk of treatment-related toxicities may also be explored. Discussion Potential collaborations with other longitudinal studies (e.g. U-CAN) with biologic sample collection is feasible.