The Impact of Emotional Distress on First Line Therapy in Patients With Metastatic Breast Cancer (EIRENE): a Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 试验地点
- 68
- 主要终点
- Progression-free survival (PFS), according to the presence of ED at T0, in cohort A
研究概览
简要总结
Few data about the impact of emotional distress (ED) on treatment efficacy in patients with metastatic breast cancer (mBC) are available.
Aim of this study is to assess the outcomes of patients with mBC receiving first-line treatment according to the presence of baseline ED.
详细描述
Metastatic breast cancer (mBC) is the most incident and prevalent cancer in the world and, according to a recent meta-analysis, 50% of patients with BC report emotional distress (ED).
In patients with cancer, ED negatively impacts treatment adherence, ability to self-manage the physical and emotional consequences of cancer symptoms and treatment-related adverse events, and overall quality of life. ED has been shown to directly affect treatment outcomes in patients with breast cancer, with studies demonstrating that psychological well-being plays a critical role in therapeutic success.
Furthermore, recent studies showed that baseline ED is associated with a lower efficacy of immunotherapy in patients with non-small cell lung cancer (NSCLC) or melanoma.
Few data about the impact of ED on treatment efficacy in patients with mBC are available. In the first line setting patients receive endocrine therapy, chemotherapy, immunotherapy and/or targeted therapy according to the disease subtype. These agents display different mechanisms of action, which involve the immune system at different levels. However, the role of ED on the efficacy of these treatments according to the BC subtype is unknown.
Aim of this study is to assess the outcomes of patients with mBC receiving first-line treatment according to the presence of baseline ED.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Age over 18 years
- •Confirmed histological diagnosis of breast cancer
- •No prior treatment for advanced/metastatic cancer
- •Indication to receive first-line therapy as per standard clinical practice based on the disease subtype:
- •cohort A (HR-/HER2-, PD-L1+): pembrolizumab or atezolizumab + chemotherapy
- •cohort B (HR-/HER2-, PD-L1-): chemotherapy
- •cohort C (HR+/HER2-): CDK4/6 inhibitor + endocrine therapy
- •cohort D (HER2+): chemotherapy + trastuzumab and pertuzumab
- •Presence of measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1 and/or Positron Emission Tomography Response Criteria in Solid Tumors (PERCIST) criteria
- •Able to provide full informed consent for the study
排除标准
- •Pre-existing severe psychiatric disorders or other conditions that could impair the ability to provide informed consent
- •Inability to complete questionnaires
- •Presence of another malignancy in the previous 3 years
- •Symptomatic brain metastases
- •Ongoing treatment with antidepressant and/or anxiolytic drugs
研究组 & 干预措施
Cohort D (HER2+)
HER2+ mBC patients receiving chemotherapy + trastuzumab and pertuzumab
干预措施: ED and quality of life assessment (Behavioral)
Cohort A (HR-/HER2-, PD-L1+)
Triple-negative Programmed Cell Death Ligand 1 (PD-L1)+ mBC patients receiving chemotherapy with immune checkpoint inhibitors (ICIs)
干预措施: ED and quality of life assessment (Behavioral)
Cohort B (HR-/HER2-, PD-L1-)
Triple-negative PD-L1- mBC patients receiving chemotherapy
干预措施: ED and quality of life assessment (Behavioral)
Cohort C (HR+/HER2-)
HR+/HER2- mBC patients receiving Cyclin-Dependent Kinase 4/6 (CDK4/6) inhibitor + endocrine therapy
干预措施: ED and quality of life assessment (Behavioral)
结局指标
主要结局
Progression-free survival (PFS), according to the presence of ED at T0, in cohort A
时间窗: 2 years
Time from T0 (Cycle 1 Day 1) to disease progression or death
次要结局
- Progression-free survival (PFS), according to the presence of ED at T0, in cohort B, C and D(2 years)
- Progression-free survival (PFS), according to the presence of ED at T1 (Cycle 3 Day 1)(2 years)
- Objective response rate (ORR), according to the presence of ED at T0 and T1(2 years)
- Quality of life evaluation(3 months)
- Fear of cancer progression evaluation(3 months)