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)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- To evaluate the feasibility of incorporating a molecular diagnosis in the management of patients with metastatic breast cancer following a patient-centric strategy.
研究概览
简要总结
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.
详细描述
HOPE Focus - SOLTI-2401 is a prospective, patient-centered research initiative designed to enhance the treatment of patients with MBC through advanced molecular diagnosis in a real-world clinical setting. It uniquely empowers patients to actively participate in their care, from inclusion and data provision to follow-up, utilizing a web-based digital tool (DT) that streamlines their entire journey within the study. The DT not only facilitates seamless communication between patients and the research team, but also serves as a comprehensive repository for relevant study information.
Patients will lead their own inclusion and participation, providing follow-up data through the DT that will guide them during all their journey in the study. After registration and after undergoing an informative interview, eligible patients will provide electronic signature of the informed consent form, and information about their demographic characteristics and relevant oncological information, all through the DT. In addition, the tool will guide them to attend the closest local partner laboratory to:
- Sign a paper version of the informed consent form if it cannot be signed electronically.
- Hand over a tissue block retrieved from their hospital for molecular diagnosis.
- Provide blood for plasma extraction and ctDNA analysis if their disease is progressing to the last line of therapy (liquid biopsy).
The DT will be a reference for patients of the status of their case within the study and will be the main repository of the ICF, clinical information provided by patients, sequencing results and reports generated after Molecular Advisory Board (MAB )discussion. Finally, there will be a three-year active follow-up to capture the impact of molecular diagnosis using the DT.
At the time of disease progression and preferably before the initiation of a new line of therapy, blood will be collected at the closest venue of the partner laboratory. Plasma samples will be tested using a NGS comprehensive panel and a standard genomics report will be generated afterwards.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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-
- •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.
排除标准
- •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.
结局指标
主要结局
To evaluate the feasibility of incorporating a molecular diagnosis in the management of patients with metastatic breast cancer following a patient-centric strategy.
时间窗: Ongoing basis during 5 years of study duration
Percentage of patients with a valid NGS test and a treatment recommendation by the Molecular Advisory Board.
次要结局
- 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)
- To describe the genomic landscape of MBC in a real-world population beyond clinical trials using validated targeted sequencing assays in tissue and ctDNA. Frequency of MBC gene mutations in the study population.(Ongoing basis during 5 years of study duration)