NCT04497285Active, not recruiting
Real World Study Using Comprehensive Genomic Data on the Next Treatment Decision Making in Metastatic Breast Cancer
HOPE: Real World Clinical Practice Study to Assess the Impact of Using Comprehensive Genomic Data on the Next Treatment Decision Making Choice in Patients With Locally Advanced or Metastatic Breast Cancer in Spain
Source: ClinicalTrials.gov · Last updated 6 Aug 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 600 (estimated)
- First submitted
- 3 Jul 2020
- Start date
- 20 Oct 2020
- Primary completion date
- 30 Jul 2023
- Lead sponsor
- SOLTI Breast Cancer Research Group
- Diseases
- Metastatic breast cancer
- NCT number
- NCT04497285
What you commit to
- Study type: Observational
- Planned participants: 600
- From 20 Oct 2020 to the primary completion date, 30 Jul 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- Inability to consent or conform to the processes involved in a clinical study.
Who the study is looking for
- Female or Male patients.
- Age ≥18 years.
- Signed informed consent prior to any screening procedure.
- Locally advanced or metastatic breast cancer of any subtype confirmed both pathologically and radiologically (stage IIIb- IV disease).
- 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.
- Availability of one metastatic (preferably), primary tumor sample or blood sample.
- Measurable or non-measurable disease.
- Quality of life score according to ECOG scale ≤ 3.
- Minimal life expectancy of 6 months.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Translational Genomics and Targeted Therapeutics in Solid Tumours Lab in August Pi i Sunyer Biomedical Research Institute (IDIBAPS) Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.