Abstract OT2-04-02: A non-interventional study to characterize the real world treatment patterns and outcomes of women with ER+, HER2- advanced or metastatic breast cancer in Italy
Authors: De Laurentiis M , Mitra D , Bell T , Nuzzo CMA , De Placido S 
Published: May 2016

Abstract
Background: Breast cancer is the most common type of cancer in women. There were an estimated 1.67 million new cases of breast cancer worldwide in 2012. Approximately 75% of women have hormone receptor positive (ER positive or PR positive) disease (Buzdar et al., 2009) and most of these patients have HER2-negative disease (Partridge et al., 2014). Although there is evidence via clinical trials on the efficacy of a number of ER+, HER2- breast cancer treatments, real world treatment patterns and related outcomes among this population are poorly characterized. This study aims at examining real world practice patterns and its impact on outcomes to gain a better understanding of the limitations of current treatments, identify specific areas and subpopulations with the greatest unmet need, and demonstrate the economic impact of current treatments. Additionally, this study will provide a longitudinal assessment of the impact of breast cancer on quality of life and work productivity in this subpopulation.
Study design: This study uses a prospective, observational cohort design. Approximately 500 women with ER+, HER2- ABC or mBC within Italy will be enrolled across 50 to 80 sites that represent diverse geographical and treatment settings. All patients will be followed for a minimum of two years (or until patient withdrawal from the study, death, or study discontinuation).
Eligibility criteria: Women who have been diagnosed with ER+, HER2- mBC or locoregionally recurrent ABC not amenable to resection or radiation therapy with curative intent and are initiating their first or second therapy in the ABC/mBC setting will be eligible to participate. Patients could have a de novo diagnosis of ABC or mBC or recur from an earlier stage. Patients participating in any interventional clinical trial that includes investigational products at the time of enrollment will be excluded from the study.
Specific aims: The key measures of interest are demographic and clinical characteristics, treatment patterns, clinical outcomes (e.g. objective response, progression-free survival, and overall survival, disease specific health care resource use, patient reported quality of life (EQ-5D), work productivity (WPAI-SHP), and disease specific symptoms and functioning (FACT-B and FACT-ES).
Statistical methods: The study is descriptive and not designed for formal hypothesis testing. A sample size of 500 patients ensures that the half-width of the 95% CIs on the proportion of patients with objective response at one year is less than 0.06.
Accrual: Patient enrollment is expected to begin in September 2015.
Disclosure: This study is sponsored by Pfizer Inc.
Citation Format: De Laurentiis M, Mitra D, Bell T, Nuzzo CMA, De Placido S. A non-interventional study to characterize the real world treatment patterns and outcomes of women with ER+, HER2- advanced or metastatic breast cancer in Italy. [abstract]. In: Proceedings of the Thirty-Eighth Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2015 Dec 8-12; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2016;76(4 Suppl):Abstract nr OT2-04-02.