Frontiers in Oncology (Apr 2023)

HOPE (SOLTI-1903) breast cancer study: real-world, patient-centric, clinical practice study to assess the impact of genomic data on next treatment decision-choice in patients with locally advanced or metastatic breast cancer

  • Rubén Olivera-Salguero,
  • Elia Seguí,
  • Elia Seguí,
  • Elia Seguí,
  • Juan Miguel Cejalvo,
  • Juan Miguel Cejalvo,
  • Mafalda Oliveira,
  • Mafalda Oliveira,
  • Mafalda Oliveira,
  • Pablo Tolosa,
  • Pablo Tolosa,
  • Maria Vidal,
  • Maria Vidal,
  • Maria Vidal,
  • Maria Vidal,
  • Marcos Malumbres,
  • Marcos Malumbres,
  • Marcos Malumbres,
  • Joaquín Gavilá,
  • Joaquín Gavilá,
  • Cristina Saura,
  • Cristina Saura,
  • Sonia Pernas,
  • Sonia Pernas,
  • Rafael López,
  • Rafael López,
  • Mireia Margelí,
  • Mireia Margelí,
  • Judith Balmaña,
  • Judith Balmaña,
  • Montserrat Muñoz,
  • Montserrat Muñoz,
  • Montserrat Muñoz,
  • Isabel Blancas,
  • Isabel Blancas,
  • Valentina Boni,
  • Valentina Boni,
  • Eva Ciruelos,
  • Eva Ciruelos,
  • Eva Ciruelos,
  • Elena Galve,
  • Elena Galve,
  • Antonia Perelló,
  • Antonia Perelló,
  • Rodrigo Sánchez-Bayona,
  • Rodrigo Sánchez-Bayona,
  • Susana de la Cruz,
  • Susana de la Cruz,
  • Miguel de la Hoya,
  • Patricia Galván,
  • Esther Sanfeliu,
  • Esther Sanfeliu,
  • Esther Sanfeliu,
  • Blanca Gonzalez-Farre,
  • Blanca Gonzalez-Farre,
  • Blanca Gonzalez-Farre,
  • Valeria Sirenko,
  • Aura Blanch-Torras,
  • Jordi Canes,
  • Helena Masanas,
  • Rosa Olmos,
  • Margarita Forns,
  • Aleix Prat,
  • Aleix Prat,
  • Aleix Prat,
  • Aleix Prat,
  • Ana Casas,
  • Ana Casas,
  • Tomás Pascual,
  • Tomás Pascual

DOI
https://doi.org/10.3389/fonc.2023.1151496
Journal volume & issue
Vol. 13

Abstract

Read online

BackgroundMetastatic breast cancer (mBC) causes nearly all BC-related deaths. Next-generation sequencing (NGS) technologies allow for the application of personalized medicine using targeted therapies that could improve patients’ outcomes. However, NGS is not routinely used in the clinical practice and its cost induces access-inequity among patients. We hypothesized that promoting active patient participation in the management of their disease offering access to NGS testing and to the subsequent medical interpretation and recommendations provided by a multidisciplinary molecular advisory board (MAB) could contribute to progressively overcome this challenge. We designed HOPE (SOLTI-1903) breast cancer trial, a study where patients voluntarily lead their inclusion through a digital tool (DT). The main objectives of HOPE study are to empower mBC patients, gather real-world data on the use of molecular information in the management of mBC and to generate evidence to assess the clinical utility for healthcare systems.Trial designAfter self-registration through the DT, the study team validates eligibility criteria and assists patients with mBC in the subsequent steps. Patients get access to the information sheet and sign the informed consent form through an advanced digital signature. Afterwards, they provide the most recent (preferably) metastatic archival tumor sample for DNA-sequencing and a blood sample obtained at the time of disease progression for ctDNA analysis. Paired results are reviewed by the MAB, considering patient’s medical history. The MAB provides a further interpretation of molecular results and potential treatment recommendations, including ongoing clinical trials and further (germline) genetic testing. Participants self-document their treatment and disease evolution for the next 2 years. Patients are encouraged to involve their physicians in the study. HOPE also includes a patient empowerment program with educational workshops and videos about mBC and precision medicine in oncology. The primary endpoint of the study was to describe the feasibility of a patient-centric precision oncology program in mBC patients when a comprehensive genomic profile is available to decide on a subsequent line of treatment.Clinical trial registrationwww.soltihope.com, identifier NCT04497285.

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