FDG-PET/CT Versus Conventional CT for Response Monitoring in Metastatic Breast Cancer: A Multicenter Randomized Clinical Trial (MONITOR-RCT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 420
- 试验地点
- 20
- 主要终点
- Overall survival
研究概览
简要总结
Several studies have shown improved sensitivity of FDG-PET/CT compared with conventional imaging for diagnosing metastatic breast cancer in retrospective and smaller prospective studies. For response monitoring, we expect FDG-PET/CT to detect disease progression earlier than CT in patients treated for metastatic breast cancer, enabling earlier start of second-line therapies.
Current knowledge about the potential benefit of FDG-PET/CT for response monitoring of patients with metastatic breast cancer comes from observational studies. Consequently, current evidence is only hypothesis-generating and prospective, randomized trials such as the MONITOR-RCT are needed to corroborate these findings.
The MONITOR-RCT clinical trial aims to investigate whether monitoring with FDG-PET/CT can improve survival in patients diagnosed with metastatic breast cancer. It is a parallel group comparative randomized trial comparing an experimental monitoring strategy based on FDG-PET/CT with a standard monitoring strategy based on CT.
Participating patients should have newly diagnosed metastatic breast cancer and be considered eligible for initiating first-line medical treatment and subsequent regular response monitoring. A total of 420 patients will be included in the study, with recruitment taking place across 11 participating hospital sites in Denmark, Germany, and Italy.
The main questions it aims to answer are:
- Can monitoring with FDG-PET/CT compared to conventional CT prolong the overall survival of MBC patients?
- Is this-as expected-due to earlier detection of disease progression and earlier initiation of second-line therapies?
- Is this accompanied by less need for additional diagnostics, less need for hospitalization, and improved quality of life?
Participants will:
- Undergo FDG-PET/CT scans at scheduled intervals to monitor disease progression.
- Be given standard treatments as part of oncological care, which is informed by the FDG-PET/CT scans
- Fill out questionnaires about their quality of life at various time points throughout the study.
Objectives are:
Primary: To demonstrate superiority in overall survival of response monitoring with FDG-PET/CT in patients with metastatic breast cancer over response monitoring based on CT. Appropriately adapted PERCIST criteria for FDG-PET/CT and the RECIST1.1 criteria for CT will be used.
Secondary: To demonstrate superiority in quality of life and exposure to oncologic treatment with FDG-PET/CT and to investigate the cost-effectiveness.
详细描述
Background Breast cancer is the most commonly diagnosed cancer in Europe and worldwide. With a continuously increasing incidence, it is estimated that by 2040, the breast cancer burden will increase to more than three million new cases per year worldwide, with more than one million breast cancer-related deaths per year (50% increase).
The prognosis of breast cancer is steadily improving due to the early detection of primary cancer through screening programs and revolutionising treatment development. Despite this, approximately one-third of patients diagnosed with primary breast cancer will develop metastatic disease. In the metastatic setting, therapy improvements have made breast cancer a chronic disease with declining mortality rates, and several effective treatment lines are available for metastatic breast cancer patients today and in the future. This favourable situation requires accurate methods to assess response to treatment to achieve the most effective treatment planning.
FDG-PET/CT is increasingly used in cancer staging. Several studies have shown improved sensitivity of FDG-PET/CT compared with conventional imaging for diagnosing metastatic breast cancer in retrospective and smaller prospective studies. We expect FDG-PET/CT to detect disease progression earlier than CT in patients treated for metastatic breast cancer, enabling earlier start of second-line therapies. This has the potential to increase the beneficial effect of second-line therapies at the individual level and result in a delayed need for third-line therapies, prolonged overall survival, and improved quality of life compared with patients monitored with conventional CT.
Currently, no specific recommendations are provided for a diagnostic modality to monitor treatment response in patients with metastatic breast cancer. European clinical practice guidelines (ESMO) state that there is no evidence of any staging or monitoring approach for metastatic breast cancer patients that provides overall survival benefit over another approach. ESMO suggests that FDG-PET/CT might provide earlier guidance in the monitoring of bone-only or bone-predominant metastasis, but it is emphasised that prospective trials are needed to study the impact of this on treatment decisions and overall survival. This is the evidence that MONITOR-RCT will deliver.
Study objectives The primary objective of the MONITOR-RCT is to demonstrate that in patients with metastatic breast cancer, response monitoring based on FDG-PET/CT is superior to response monitoring based on CT with respect to overall survival. The objective will be based on applying standardized response evaluation criteria, using an appropriate adaptation of the PERCIST criteria for FDG-PET/CT and the RECIST1.1 criteria for CT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Women and men aged ≥18 years
- •Diagnosis of distant relapsed MBC (biopsy-verified) or de novo breast cancer. In patients with distant relapsed MBC, biopsy verification from a distant metastasis is required. In patients with de novo MBC, biopsy verification of primary tumor and diagnostic imaging with distant metastasis with a typical pattern of MBC is required.
- •Considered eligible for first-line systemic treatment
- •Considered eligible for continuous treatment monitoring by scans.
- •Signed informed consent
- •Participants must have the ability to read and understand the following languages based on their country of participation: in Denmark, patients must be able to read and understand Danish; in Italy, they must be able to read and understand Italian or English; and in Germany, they must be able to read and understand German or English.
- •In case of patients for whom it is necessary to start first-line systemic treatment while still waiting for the evaluation of the biopsy, it is allowed to include the patients, as long as the other criteria are fulfilled and the biopsy is made or planned. In case verification by biopsy fails, the patients will leave the trial (cf. 4c). We expect that up to 3% of the patients included will start first-line systemic treatment prior to evaluation of the biopsy
排除标准
- •Pregnant or lactating women
- •Ongoing oncological treatment for another cancer
- •Exclusively brain metastasis
- •Allergy to FDG
研究组 & 干预措施
FDG-PET/CT
Monitoring of patients with FDG-PET/CT
干预措施: FDG-PET/CT (Diagnostic Test)
CT
Monitoring of patients with current standard.
干预措施: CE-CT (Diagnostic Test)
结局指标
主要结局
Overall survival
时间窗: From date of randomization until the date of death assessed up to 54 months.
Time from randomization until death for any reason
次要结局
- Time from first to second progression(From date of first documented progression until the date of second documented progression assessed up to 54 months.)
- Time from second to third progression(From date of second documented progression until the date of third documented progression assessed up to 54 months.)
- Hospitalization(The corresponding events will be continuously documented from randomization for up to 54 months.)
- Experiencing other diagnostic procedures(The corresponding events will be continuously documented from randomization for up to 54 months.)
- Quality of life: FACT-B(Measured at baseline, after 3, 6, 9, 12, 18, 24, 30, 36, 42, 48 and 54 months - if the patient is still alive. Average over all time points wil be reported.)
- Quality of Life: Patient complaints(Assessed at baseline, after 3, 6, 9, 12, 18, 24, 30, 36, 42, 48 and 54 months - if the patient is still alive. Reporting will not be time point specific.)
- Experience of progression(The corresponding events will be continuously documented from randomization for up to 54 months.)
- Start of a new treatment line due to progression(The corresponding events will be continuously documented from randomization for up to 54 months.)
- Time to first progression(From date of randomization until the date of first documented progression assessed up to 54 months.)
- Cost effectiveness(EQ-5D-5L will be assessed after 0, 3, 6, 9, 12, 18, 24, 30, 36, 42, 48, and 54m. Survival will be assessed as described above. Costs are based on continouos documentation of treatment/scans and on registry data. All data will be assessed up to 54 months.)