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Clinical Trials in Spain / NCT04497285
Active, not recruiting Observational

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

NCT04497285 · tracked via the Priya Life Science Spain tracker
Phase
Observational
Started
2020-10-20
Last updated
2025-08-06

Condition(s) studied

Metastatic Breast Cancer

Investigational drug(s) / intervention(s)

blood sample collection and collection of tumor tissue block

blood sample collection and collection of tumor tissue block: blood sample collection and collection of tumor tissue block

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Female or Male patients. 2. Age ≥18 years. 3. Signed informed consent prior to any screening procedure. 4. Locally advanced or metastatic breast cancer of any subtype confirmed both pathologically and radiologically (stage IIIb- IV disease). 5. The subjects must be about to receive, or receiving, or will have completed treatment for their metastatic disease with any line of treatment in either a clinical trial or the healthcare setting. 6. Availability of one metastatic (preferably), primary tumor sample or blood sample. 7. Measurable or non-measurable disease. 8. Quality of life score according to ECOG scale ≤ 3. 9. Minimal life expectancy of 6 months. Exclusion Criteria: 1. Inability to consent or conform to the processes involved in a clinical study. 2. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Translational Genomics and Targeted Therapeutics in Solid Tumours Lab in August Pi i Sunyer Biomedical Research Institute (IDIBAPS) Barcelona Please Select

More SOLTI Breast Cancer Research Group trials in Spain

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04497285 on ClinicalTrials.gov ↗ ← All trials in Spain