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)

Status: Recruiting
Location: See location...
Intervention Type: Genetic
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Spain
SOLTI Cancer Research Group
RECRUITING
Barcelona
Time Frame
Start Date: 2025-05-20
Estimated Completion Date: 2030-05-20
Participants
Target number of participants: 300
Treatments
Metastatic breast cancer of any subtype
Patients with metastatic breast cancer of any subtype that have progressed after at least one line of treatment in the metastatic setting
ER+/HER2- metastatic breast cancer
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
Related Therapeutic Areas
Sponsors
Collaborators: Menarini Group, Eli Lilly and Company, Pfizer, AstraZeneca, Roche Farma, S.A
Leads: SOLTI Breast Cancer Research Group

This content was sourced from clinicaltrials.gov