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

Active Not RecruitingN/A

Sponsor: SOLTI Breast Cancer Research Group

Conditions: Metastatic Breast Cancer

Interventions: blood sample collection and collection of tumor tissue block

Countries: Spain

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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.

Locations (1)

Barcelona, Please Select, Spain