Assessing Genomic Profiling's Impact on Metastatic Breast Cancer Treatment in Spain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

HOPE Focus is an observational initiative aimed at enhancing the treatment of metastatic breast cancer (MBC) through patient-led genomic profiling. Patients in Spain will voluntarily register and provide data via a digital tool, including blood samples and tumor biopsies for genomic analysis. Their cases will be discussed in a multidisciplinary molecular advisory board, which will offer personalized treatment options based on their genomic profiles. Patients will also complete follow-up questionnaires biannually for three years to track their progress.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Female or male patients residing in Spain.
2. Age ≥ 18 years.
3. Signed informed consent prior to any study-related procedures, except for registration.
4. Self-reported Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
5. Patients with metastatic breast cancer in at least one of these situations:

   1. Patients recently diagnosed with ER+/HER2- metastatic breast cancer as a recurrence during adjuvant treatment and prior to initiating any treatment in the metastatic setting.
   2. Patients with metastatic breast cancer of any subtype that have progressed after at least one line of treatment in the metastatic setting.

Exclusion Criteria:

1. Presence of a condition or abnormality that, in the opinion of the investigators, would compromise the safety of the patient or the quality of the data.
2. Inability or refusal to commit with the procedures of the study at the moment of inclusion.
3. More than 3 prior systemic chemotherapy or antibody-drug conjugate (ADC) regimens for metastatic disease. Note: treatments for bone metastases (eg, bisphosphonates, denosumab, etc.), targeted therapies (eg, PARP inhibitors, CDK 4/6 inhibitors, immunotherapy etc.) and hormonal therapy are not considered as prior systemic chemotherapy treatments for advanced disease.

Where it's running

• SOLTI Cancer Research Group
  Barcelona, Barcelona, Spain Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.