Actively Recruiting

Age: 18Years +
All Genders
NCT06991946

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

Led by SOLTI Breast Cancer Research Group · Updated on 2025-05-28

300

Participants Needed

1

Research Sites

260 weeks

Total Duration

On this page

Sponsors

S

SOLTI Breast Cancer Research Group

Lead Sponsor

R

Roche Farma, S.A

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Female or male patients residing in Spain
  • Age 18 years or older
  • Signed informed consent before any study procedures (except registration)
  • Self-reported ECOG performance status of 0 or 1
  • Diagnosed with metastatic breast cancer either recently diagnosed ER+/HER2- recurrence before metastatic treatment or progressed after at least one metastatic treatment line
Not Eligible

You will not qualify if you...

  • Any condition that could compromise patient safety or data quality
  • Inability or refusal to follow study procedures at inclusion
  • More than 3 prior systemic chemotherapy or antibody-drug conjugate treatments for metastatic disease (excluding bone metastases treatments, targeted therapies, or hormonal therapy)

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

SOLTI Cancer Research Group

Barcelona, Barcelona, Spain, 08008

Actively Recruiting

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How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Patient-Centric Study to Assess the Impact of Genomic Profiling on the Treatment of Patients With Metastatic Breast Cancer in Spain | DecenTrialz