Abstract OT-17-01: Solti-1903 hope: Real-world clinical practice study to assess the impact of using comprehensive genomic data on the next treatment decision making-choice in patients with locally advanced or metastatic breast cancer in Spain
Authors: Casas Ana , Ciruelos Eva , Oliveira Mafalda , Saura Cristina , Bellet Meritxell , Pernas Sonia , Gavilá Joaquín , Muñoz Montserrat , Vidal María , Farré Blanca Gonzalez , Cejalvo Juan M. , Lopez Rafael , Vivancos Ana , Scaltriti Maurizio , Bofill Javier S. , Blancas Isabel , Alba Emilio , Boni Valentina , De la Cruz Susana , Galve Elena , Perelló Antonia , Margelí Mireia , Canes Jordi , Céliz Pamela , Masanas Helena , Olmos Rosa , Fonts Marga , Fernandez-Pascual Pilar , Villagrasa Patricia , Prat Aleix 
Published: February 2021

Abstract
BACKGROUND: Metastatic breast cancer (mBC) remains an incurable disease and is the cause of nearly all deaths from breast cancer. Targeted molecular therapies and the evolving role of next-generation sequencing (NGS) technologies are increasing and may improve outcomes in breast cancer patients. However, they are not being routinely used in the clinic. One strategy to overcome the barriers of implementing NGS in the clinic is to promote the active participation of mBC patients in the management of their disease. With this in mind, we designed HOPE (SOLTI-1903), a national real-world study where patients lead their inclusion, participation and follow-up in the study through a digital tool that will guide them in every step of the journey. Our objective is empowering mBC patients and gather real-world data about the utilization of molecular information in the management of mBC. TRIAL DESIGN: Patients diagnosed with mBC who are receiving, have just received, or will receive standard treatment or treatment in a clinical trial (CT) can be included. Demographic data, disease characteristics, treatment history and quality of life data will be collected through a digital tool (DT) by the patient. Patients are encouraged to involve their physician`s in the study journey. The study is complemented by a patient empowerment program including informative workshops and precision medicine video-tutorials. A total of 600 patients will be included in Spain. Patient Journey Once patients request to participate in HOPE through the DT, a dedicated team from SOLTI will assist them in the following steps while validating that eligibility criteria are met according to data introduced by themselves. Then, patients will receive instructions via DT to go to the nearest partner local laboratory, where they will sign the study consent form. A metastatic (preferably) or primary archival tumor sample will be requested to the patient’s reference hospital and analyzed by FoundationOne®CDx. Also, a blood sample will be collected and analyzed by Guardant360. For all patients, two NGS tests will be offered (If no tissue available, only blood test will be performed). Both molecular analyses results will be reviewed during regular meetings by a Molecular Advisory Board (MAB). The MAB, based on their joint experience in clinical oncology, genomics, molecular biology, bioethics and pathology, may add some advice to these reports via DT, making comments about detected molecular alterations and adding further recommendations for specific treatment options or available CT with targeted therapies. From that moment, patients will record their disease evolution in the DT each 3 months for 2 years. The primary objective is to assess the real-world clinical practice integrating molecular profiling in the Standard of Care management of mBC patients connected through a DT. Secondary objectives include to describe genetic mutational profile of mBC, to evaluate the enrollment rate in CT of patients engaged in a patient-centered strategy for molecular tumor assessment, to asses Progression Free Survival, Overall Survival and Quality of life status among patients enrolled in CT according to the tumor’s genomic profile and those receiving standard treatment and to describe logistic feasibility of the study. This study is sponsored by SOLTI and financially supported by Novartis and two non-profit organizations: Asociación Cáncer de Mama Metastásico y Fundación Actitud frente al Cáncer. Roche and Guardant Health provide their test for all patients.
Citation Format: Ana Casas, Eva Ciruelos, Mafalda Oliveira, Cristina Saura, Meritxell Bellet, Sonia Pernas, Joaquín Gavilá, Montserrat Muñoz, María Vidal, Blanca Gonzalez Farré, Juan M. Cejalvo, Rafael Lopez, Ana Vivancos, Maurizio Scaltriti, Javier S. Bofill, Isabel Blancas, Emilio Alba, Valentina Boni, Susana De la Cruz, Elena Galve, Antonia Perelló, Mireia Margelí, Jordi Canes, Pamela Céliz, Helena Masanas, Rosa Olmos, Marga Fonts, Pilar Fernandez-Pascual, Patricia Villagrasa, Aleix Prat. Solti-1903 hope: Real-world clinical practice study to assess the impact of using comprehensive genomic data on the next treatment decision making-choice in patients with locally advanced or metastatic breast cancer in Spain [abstract]. In: Proceedings of the 2020 San Antonio Breast Cancer Virtual Symposium; 2020 Dec 8-11; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2021;81(4 Suppl):Abstract nr OT-17-01.