NCT06991946

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 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
49mo left

Started May 2025

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress19%
May 2025May 2030

First Submitted

Initial submission to the registry

May 19, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

May 20, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 28, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2027

Expected
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2030

Last Updated

May 28, 2025

Status Verified

May 1, 2025

Enrollment Period

2 years

First QC Date

May 19, 2025

Last Update Submit

May 19, 2025

Conditions

Metastatic Breast Cancer

Keywords

molecular advisory boardmolecular tumor boardgenomic datatargeted therapypatient-centric trialobservational trialMolecular datagenomic analysisliquid biopsytumor block

Outcome Measures

Primary Outcomes (1)

  • To evaluate the feasibility of incorporating a molecular diagnosis in the management of patients with metastatic breast cancer following a patient-centric strategy.

    Percentage of patients with a valid NGS test and a treatment recommendation by the Molecular Advisory Board.

    Ongoing basis during 5 years of study duration

Secondary Outcomes (6)

  • To study the clinical impact of genomic testing in terms of matched therapies prescribed by treating physicians

    Ongoing basis during 5 years of study duration

  • Description of Overall Survival (OS) and Progression Free Survival/Time to Next Treatment (PFS/TTNT) of matched treatments.

    Ongoing basis during 5 years of study duration

  • To study the clinically actionable targets (based on ESCAT) detected using tissue targeted sequencing, and plasma ctDNA targeted sequencing.

    Ongoing basis during 5 years of study duration

  • To study the impact of a liquid biopsy based molecular diagnostic in patients with ER+/HER2- BC whose disease progresses as a recurrence during the adjuvant treatment or as a failure of the 1L of treatment or subsequent in the metastatic setting of patie

    Ongoing basis during 5 years of study duration

  • To study the concordance rate for key genomic alterations between ctDNA and tumor targeted sequencing (in a subset of patients who have both samples available).

    Ongoing basis during 5 years of study duration

  • +1 more secondary outcomes

Study Arms (2)

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

Genetic: Liquid BiopsyGenetic: Archival Tumor DNA

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

Genetic: Liquid BiopsyGenetic: Archival Tumor DNA

Interventions

Liquid BiopsyGENETIC

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

ER+/HER2- metastatic breast cancerMetastatic breast cancer of any subtype
Archival Tumor DNAGENETIC

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

ER+/HER2- metastatic breast cancerMetastatic breast cancer of any subtype

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with metastatic breast cancer living and being treated in Spain.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SOLTI Cancer Research Group

Barcelona, Barcelona, 08008, Spain

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample collection and archival tumor tissue collection

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Liquid Biopsy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

BiopsyCytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingInvestigative Techniques

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2025

First Posted

May 28, 2025

Study Start

May 20, 2025

Primary Completion (Estimated)

May 20, 2027

Study Completion (Estimated)

May 20, 2030

Last Updated

May 28, 2025

Record last verified: 2025-05

Locations

ES(1)