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SOLTI Breast Cancer Molecular Screening Program (AGATA)

NCT02445482 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 260

Last updated 2019-01-09

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Biopsy

archival tissue or fresh biospsy

Sponsors & Collaborators

  • SOLTI Breast Cancer Research Group

    lead OTHER

Principal Investigators

  • Eva Ciruelos, MD · SOLTI Breast Cancer Research Group

  • Sonia Pernas, MD · SOLTI Breast Cancer Research Group

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2017-06-30
Completion
2018-12-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02445482 on ClinicalTrials.gov