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.
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.
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.
Patients diagnosed with metastatic breast cancer living and being treated in Spain.
Other
Prospective
Liquid Biopsy
GeneticPatients with metastatic breast cancer in disease progression will undergo a liquid biopsy
Archival Tumor DNA
GeneticPatients will be prompted to request an archival tumor sample from metastatic origin (preferably) and to send it to the central laboratory for analysis
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.
To study the clinical impact of genomic testing in terms of matched therapies prescribed by treating physicians
* Percentage of patients who received a matched therapy against an alteration detected by ctDNA and/or tissue targeted sequencing. * Subanalysis based on physician's participation in the study.
Description of Overall Survival (OS) and Progression Free Survival/Time to Next Treatment (PFS/TTNT) of matched treatments.
* Describe PFS/TTNT with treatments directed to molecular targets identified. * Describe OS from the moment of registration to the death of the patient.
To study the clinically actionable targets (based on ESCAT) detected using tissue targeted sequencing, and plasma ctDNA targeted sequencing.
Proportion of patients with putatively targetable (ESCAT levels I-II) alterations detected in tissue and plasma ctDNA.
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
* ctDNA detection rate in patients with 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 patients from any subtype. * Frequency of mutations identified in ctDNA, distribution of VAFs and the proportion of patients with a targetable mutation in patients with 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 patients from any subtype.
Click on the lead sponsor to view all of their trials.
SOLTI Breast Cancer Research Group
Lead sponsor
Roche Farma, S.A
Collaborator
Menarini Group
Collaborator
AstraZeneca
Collaborator
Pfizer
Collaborator
Eli Lilly and Company
Collaborator
