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)
Metastatic breast cancer management based on tumor molecular profile — 1 year after end of accrual The number of patients assigned to different treatments based on the genomic profile.
Trial sites (1)
Facility
City
Region
Status
Translational Genomics and Targeted Therapeutics in Solid Tumours Lab in August Pi i Sunyer Biomedical Research Institute (IDIBAPS)
Barcelona
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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.
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