ABREAST: A new global registry of adjuvant strategies in patients with early stage breast cancer

Abstract

576 Background: There are substantial global variations in BC incidence, diagnosis, treatment, and survival. Prospective data on pt and tumor characteristics, treatment practices, factors impacting treatment decisions, and outcomes are lacking. We report results of a pilot study in 3 countries and the launch of an international registry to provide these data for the pt cohort with early stage BC. Methods: An international panel of experts convened to develop a prospective global BC registry, ABREAST. This was designed to achieve a random sample of pts representative of each country or region and within each participating center. International participation was solicited. A unique case report form (CRF) was designed and tested in a pilot study. Female or male pts with early stage BC were eligible. After obtaining written informed consent, CRFs were completed locally via chart review. Data from the CRFs were assessed for internal consistency, and investigators were asked about the ease of completing the forms. Results: Pilot Study: Contents of the CRF included: pt demographics, BC risk factors, co-morbidities, detection and diagnostic methods, tumor biomarker status, T and N stage, physician’s assessment of 5 year (yr) recurrence, local and systemic therapeutic plan, and outcomes. Thirty-four pts were enrolled in 3 institutions in Mexico, Turkey, and Poland. The CRFs were completed in the first cohort, revised, and validated in a second cohort. Data quality was very good; investigators and research coordinators reported ease in completing the CRFs. ABREAST launch: 36,000 pts will be enrolled over 3 yrs in >60 countries. Accrual began 8 Dec 2004. Data will be collected at entry, 1 yr, and 5 yrs; CRFs will be sent via DataFax to a central data management facility using anonymous identifiers. International Scientific and Steering Committees maintain oversight of this project. Data will be analyzed based on an investigator-driven concept proposal mechanism. Conclusions: The pilot study showed that detailed data on early BC across multiple domains can be accurately collected using a simple tool in diverse countries. Thus, ABREAST was launched globally using these validated CRFs. Accrual status will be updated. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration sanofi-aventis