SOLTI Breast Cancer Molecular Screening Program (AGATA)
Condition: Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      In recent years, the advance in high-throughput techniques, such as microarrays and next gen
      sequencing (NGS) technologies, have allowed a more precise classification of the breast
      cancer molecular subtypes and a more personalized approach to anti-cancer therapy. To date,
      conventional methods to select patients for clinical trials with anti-targeted agents
      according to molecular criteria are generally limited to the analysis of a few biomarkers.
      Recent studies have shown how this strategy is inappropriate in case of infrequent molecular
      alterations and that the ideal strategy would consist in simultaneous examination of large
      numbers of actionable genomic alterations.

      This is the first genomic screening platform ever attempted in Spain. By this molecular
      platform SOLTI aims to increase the likelihood of a patient being included in a trial
      designed specifically for her molecular tumor type. Thus, the primary objective of this pilot
      study is to determine the Platform's effectiveness to include patients in clinical trials
      with targeted agents based on the tumor molecular profiling.
    

Detailed description: 
      This is a prospective, multicenter, pilot study conducted in eight sites located in Spain. Up
      to 260 female or male patients, between 18-70 years with advanced or metastatic breast cancer
      will be screened. These patients will be about to receive, or receiving, or will have
      received treatment for their disease in either a clinical trial or the healthcare setting.
      Quality of life score according to ECOG scale ≤ 2 and a minimal life expectancy of 3 months.
      Upon signed inform consent and confirmation of eligibility criteria, tumor samples will be
      obtained from the patients either by biopsy of metastatic cancer or from archived tissue
      previously available at the site, and their genomic profile will be analyzed. It will be
      assessed the mutational status of a panel of genes considered relevant to the tumor biology
      and treatment. Detected variants /mutations in samples will not be classified according to
      their origin somatic or germline, since no normal paired DNA will be analyzed. Should any
      clinical trial match the patient's molecular profile, she/he will be offered to participate
      in it and the available samples left after sequencing will be supplied when a central
      confirmation would be requested. The patient's clinical data will be collected on a quarterly
      basis until death or consent withdrawal.

      Mutation testing will be carried out at three laboratories experienced in high-throughput
      sequencing techniques: the VHIO Cancer Genomics Core laboratory of Barcelona, at Genomics
      Laboratory of the Research Institute of the Doce de Octubre University Hospital of Madrid and
      at the Genomics laboratory of the University Clinical Hospital of Valencia. There is a need
      to join efforts, set standards and optimize procedures for the benefit of all patients, so
      that the opportunity to participate in a genomic screening program can be offered to the
      great majority of hospitals that lack the technology required for these tests.
    

Intervention name(s): Biopsy
Intervention type(s): Procedure
Intervention description(s): archival tissue or fresh biospsy
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The study will be conducted in eight sites located in Spain, and up to 260 patients with
        advanced or metastatic breast cancer will be screened. These patients will be about to
        receive, or receiving, or will have received treatment for their disease in either a
        clinical trial or the healthcare setting
      
Biospecimen description: 
      Collection of the archived initial or metastatic tumor sample (one 60 μm formalin-fixed,
      paraffin-embedded tumor block). If archived material is not available, a biopsy of the
      metastatic cancer should be performed to obtain such material