NCT06991946 Patient-Centric Study to Assess the Impact of Genomic Profiling on the Treatment of Patients With Metastatic Breast Cancer in Spain
| NCT ID | NCT06991946 |
| Status | Recruiting |
| Phase | — |
| Sponsor | SOLTI Breast Cancer Research Group |
| Condition | Metastatic Breast Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2025-05-20 |
| Primary Completion | 2027-05-20 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2025-05-20 with a primary completion date of 2027-05-20.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: 1. Female or male patients residing in Spain. 2. Age ≥ 18 years. 3. Signed informed consent prior to any study-related procedures, except for registration. 4. Self-reported Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. 5. Patients with metastatic breast cancer in at least one of these situations: 1. 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. 2. Patients with metastatic breast cancer of any subtype that have progressed after at least one line of treatment in the metastatic setting. Exclusion Criteria: 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. 2. Inability or refusal to commit with the procedures of the study at the moment of inclusion. 3. 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.
Frequently Asked Questions
Who can join the NCT06991946 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Metastatic Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06991946 currently recruiting?
Yes, NCT06991946 is actively recruiting participants. Visit ClinicalTrials.gov or contact SOLTI Breast Cancer Research Group to inquire about joining.
Where is the NCT06991946 trial being conducted?
This trial is being conducted at Barcelona, Spain.
Who is sponsoring the NCT06991946 clinical trial?
NCT06991946 is sponsored by SOLTI Breast Cancer Research Group. The trial plans to enroll 300 participants.
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