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

Real-world Patient-centric Study to Assess the Feasibility of a Molecular Diagnosis on Treatment Decision Making for Patients With Metastatic Breast Cancer in Spain (HOPE-Focus)

This study is trying to see if using genetic information from patients with metastatic breast cancer in Spain can help doctors create better, personalized treatment plans for them.

Quick facts

• Study type: Observational
• Enrollment: 300 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: SOLTI Breast Cancer Research Group (Academic / other)
• Drugs / interventions: denosumab, chemotherapy, immunotherapy, radiation
• Locations: 1 site (Barcelona, Barcelona)
• Trial ID: NCT06991946 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults with metastatic breast cancer residing in Spain, particularly those recently diagnosed or who have progressed after previous treatments.

Not a fit: Patients with conditions that compromise their safety or those unable to comply with study procedures may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more personalized and effective treatment options for patients with metastatic breast cancer.

How similar studies have performed: Other studies utilizing genomic profiling in cancer treatment have shown promising results, indicating potential success for this approach.

Eligibility criteria

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 this trial is running

Barcelona, Barcelona

• SOLTI Cancer Research Group — Barcelona, Barcelona, Spain (Recruiting)

Conditions Metastatic Breast Cancer; molecular advisory board; molecular tumor board; genomic data; targeted therapy; patient-centric trial; observational trial; Molecular data