RecruitingNCT06991946

Patient-Centric Study to Assess the Impact of Genomic Profiling on the Treatment of Patients With Metastatic Breast Cancer 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)


Sponsor

SOLTI Breast Cancer Research Group

Enrollment

300 participants

Start Date

May 20, 2025

Study Type

OBSERVATIONAL

Conditions

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 breast cancer living in Spain will voluntarily register and fulfil their journey in the study through the study's digital tool. Mainly they are prompted to answer questionnaires about their disease and expectations, and to provide a blood sample and an archival tumor biopsy. In HOPE Focus these samples will be genomically analyzed and every patient case will be presented in a multidisciplinary molecular advisory board (MAB). The MAB will issue a plain report explaining the significance of the results and will enumerate future therapeutic options that match patient history and his genomic profile, when feasible. Finally, patients will have to answer short follow-up questionnaires twice a year for 3 years. The study data will allow us to advance implementing precision medicine to improve the management of current and specially future metastatic breast cancer patients.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at whether comprehensive genetic profiling of a patient's tumor can change treatment decisions and improve outcomes for people living in Spain with metastatic breast cancer. **You may be eligible if...** - You are 18 or older and live in Spain - You have metastatic breast cancer - You are either newly diagnosed with hormone receptor-positive (ER+/HER2-) metastatic disease, or your cancer has progressed after at least one line of treatment - Your overall health status is good to moderate (ECOG 0–1) **You may NOT be eligible if...** - You have received more than 3 prior chemotherapy or antibody-drug conjugate regimens for metastatic disease - You have a condition that would compromise your safety or the quality of the data - You are unable or unwilling to follow the study procedures Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

GENETICLiquid Biopsy

Patients with metastatic breast cancer in disease progression will undergo a liquid biopsy

GENETICArchival Tumor DNA

Patients will be prompted to request an archival tumor sample from metastatic origin (preferably) and to send it to the central laboratory for analysis


Locations(1)

SOLTI Cancer Research Group

Barcelona, Barcelona, Spain

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NCT06991946


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