A Prospective, Multicenter Registry to Observe the Treatment Patterns, Clinical Outcomes, and Decision-Making in Patients With Early Breast Cancer Eligible for EndoPredict® Testing
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,000
- 试验地点
- 13
- 主要终点
- Distant relapse free survival (DRFS)
研究概览
简要总结
The study is planned to observe and document the therapeutic decision-making process, treatment protocols, and clinical outcomes in patients with luminal breast cancer, whether they have undergone EndoPredict® testing or not
详细描述
PRELUDE is a prospective, multicenter, non-interventional registry designed to describe real-world treatment decision-making, treatment patterns, and long-term clinical outcomes in patients with luminal (ER-positive/HER2-negative) early breast cancer who are eligible for EndoPredict® testing, including patients who do and do not undergo the test.
The registry will be conducted at approximately 10-20 sites across Greece (with the option to add sites outside Greece if needed) and aims to enroll up to 2,000 eligible participants within 3 years. Participants may be enrolled after surgical histopathology results are available and before commencement of adjuvant endocrine treatment, and will be followed prospectively once per year for up to 10 years after surgery.
The study aims to assess 5- and 10-year clinical outcomes and to evaluate these outcomes according to EndoPredict® (EP/EPclin) risk groups or scores among patients who undergo testing, in a real-world setting. The registry will also examine which patient and disease characteristics (e.g., age, menopausal status, nodal status, histopathology, EPclin score) will influence adjuvant treatment decisions, in the context of evolving therapeutic standards and recently introduced adjuvant options.
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 ≥ 18 years old.
- •Histological diagnosis of invasive breast cancer.
- •T1-T3 tumor size.
- •0-3 positive axillary lymph nodes.
- •Documented ER-positive tumor by immunohistochemistry (≥1% or Allred Score: ≥3/8 or H-score: ≥50/ 300)
- •Documented HER2-negative tumor by immunohistochemistry and/or in situ hybridization
- •Subject with signed and dated informed consent form.
排除标准
- •History of another primary malignancy within the last 5 years, except for resected non-melanoma skin cancer.
- •Pre-operative chemotherapy administered.
- •Subject without signed and dated informed consent form.
研究组 & 干预措施
Non-metastatic breast cancer N0-N1 patients eligible for EndoPredict testing
Subjects diagnosed with non-metastatic invasive breast cancer, pT1-pT3, with 0 to 3 positive axillary lymph nodes, ER-positive, HER2-negative, that have not received neo-adjuvant chemotherapy and therefore are eligible for EndoPredict® testing. No intervention is planned, as this is an observational study and treatment of patients will not be changed due to their participation in the study.
结局指标
主要结局
Distant relapse free survival (DRFS)
时间窗: 5- and 10-years
To collect and evaluate distant relapse-free survival (DRFS) at 5 and 10 years in patients with luminal breast cancer, with analyses stratified by EPclin risk group among participants who undergo EndoPredict® testing.
Overall Survival (OS)
时间窗: 5- and 10-years
To collect and evaluate overall survival (OS) at 5 and 10 years in patients with luminal breast cancer, with analyses stratified by EPclin risk group among participants who undergo EndoPredict® testing.
Distant relapse free interval (DRFI)
时间窗: 5- and 10-years
To collect and evaluate distant relapse free interval (DRFI) at 5 and 10 years in patients with luminal breast cancer, with analyses stratified by EPclin risk group among participants who undergo EndoPredict® testing.
Proportion of adjuvant chemotherapy administration and association with baseline clinicopathologic characteristics and EPclin score
时间窗: Up to 2 months post-operatively
Proportion of participants who received adjuvant chemotherapy (yes/no) and its association with baseline clinicopathologic characteristics (age, menopausal status, nodal status, T stage, N stage, histologic grade) and EPclin score.
次要结局
- Local relapse free survival (LRFS)(5- and 10-years)
- Performance of EndoPredict (assessed with DRFS) in specific population subgroups [multifocal-multicentric disease (MFMC), node-positive, pre-menopausal women](5- and 10-years)
- Performance of EndoPredict (assessed with DRFI) in specific population subgroups [multifocal-multicentric disease (MFMC), node-positive, pre-menopausal women](5- and 10-years)
- OS in specific sub-groups (MFMC, node-positive, pre-menopausal women)(5- and 10-years)
- DRFS in specific sub-groups (MFMC, node-positive, pre-menopausal women)(5- and 10-years)
- DRFI in specific sub-groups (MFMC, node-positive, pre-menopausal women)(5- and 10-years)
- LRFS in specific sub-groups (MFMC, node-positive, pre-menopausal women)(5- and 10-years)
研究者
Michalis Kontos
Professor in Breast and General Surgery
National and Kapodistrian University of Athens