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Real World Study Using Comprehensive Genomic Data on the Next Treatment Decision Making in Metastatic Breast Cancer

NCT04497285 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 600

Last updated 2025-08-06

No results posted yet for this study

Summary

SOLTI 1903 HOPE is a national, real world clinical practice study conducted in patients diagnosed with metastatic breast cancer who are receiving, have just received or will receive treatment for its advanced disease. Patients will lead their inclusion, participation and follow-up in the study through a digital tool, but they are encouraged to include their physician's in this study. Tissue samples from metastatic (preferred) or primary tumor will be collected for analyses, together with blood samples. A Molecular Advisory Board (MAB) will assess and give recommendations according patient's molecular profile.

The primary objective is to assess the real-world clinical practice of integration of molecular profiling in the Standard of Care (SoC) management of mBC patients connected through a digital tool.

Conditions

Interventions

OTHER

blood sample collection and collection of tumor tissue block

blood sample collection and collection of tumor tissue block

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Roche Pharma AG

    collaborator INDUSTRY

  • Guardant Health, Inc.

    collaborator INDUSTRY

  • SOLTI Breast Cancer Research Group

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-20
Primary Completion
2023-07-30
Completion
2026-11-30

Countries

  • Spain

Study Locations

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Entities

Diseases
Companies

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 NCT04497285 on ClinicalTrials.gov