A pan-Canadian prospective study of young women with breast cancer: the rationale and protocol design for the RUBY study.

Introduction The understanding of the biology and epidemiology of, and the optimal therapeutic strategies for, breast cancer (Bca) in younger women is limited. We present the rationale, design, and initial recruitment of Reducing the Burden of Breast Cancer in Young Women (RUBY), a unique national prospective cohort study designed to examine the diagnosis, treatment, quality of life, and outcomes from the time of diagnosis for young women with Bca. Methods Over a 4-year period at 33 sites across Canada, the RUBY study will use a local and virtual recruitment model to enrol 1200 women with Bca who are 40 years of age or younger at the time of diagnosis, before initiation of any treatment. At a minimum, comprehensive patient, tumour, and treatment data will be collected to evaluate recurrence and survival. Patients may opt to complete patient-reported questionnaires, to provide blood and tumour samples, and to be contacted for future research, forming the core dataset from which 4 subprojects evaluating genetics, lifestyle factors, fertility, and local management or delivery of care will be performed. Summary The RUBY study will be the most comprehensive repository of data, biospecimens, and patient-reported outcomes ever collected with respect to young women with Bca from the time of diagnosis, enabling research unique to that population now and into the future. This research model could be used for other oncology settings in Canada.