Status:
RECRUITING
Patient-Centric Study to Assess the Impact of Genomic Profiling on the Treatment of Patients With Metastatic Breast Cancer in Spain
Lead Sponsor:
SOLTI Breast Cancer Research Group
Collaborating Sponsors:
Roche Farma, S.A
Menarini Group
Conditions:
Metastatic Breast Cancer
Eligibility:
All Genders
18+ years
Brief Summary
HOPE Focus is an observational study that aims at promoting research against metastatic breast cancer by means of collective research led by patients (patient-centric trial). Patients with metastatic ...
Detailed Description
HOPE Focus - SOLTI-2401 is a prospective, patient-centered research initiative designed to enhance the treatment of patients with MBC through advanced molecular diagnosis in a real-world clinical sett...
Eligibility Criteria
Inclusion
- Female or male patients residing in Spain.
- Age ≥ 18 years.
- Signed informed consent prior to any study-related procedures, except for registration.
- Self-reported Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Patients with metastatic breast cancer in at least one of these situations:
- 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.
- Patients with metastatic breast cancer of any subtype that have progressed after at least one line of treatment in the metastatic setting.
Exclusion
- 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.
- Inability or refusal to commit with the procedures of the study at the moment of inclusion.
- 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.
Key Trial Info
Start Date :
May 20 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 20 2030
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06991946
Start Date
May 20 2025
End Date
May 20 2030
Last Update
May 28 2025
Active Locations (1)
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1
SOLTI Cancer Research Group
Barcelona, Barcelona, Spain, 08008