PrEmenopausal bReaSt cancEr adjuVant thERapy Benefit According to OncotypE DX Test
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 800
- 试验地点
- 3
- 主要终点
- Invasive Disease-Free Survival (iDFS) at 5 years
研究概览
简要总结
Multicentric retroprospective observational study to collect outcome in premenopausal breast cancer patients who undergone the 21-multigene assay Oncotype DX from 1st January 2013 to 31st December 2022 and adjuvant treatment.
详细描述
Premenopausal patients who undergone the 21-multigene assay Oncotype DX from 1st January 2013 to 31st December 2022 with any Recurrence Score (RS) and pathological nodal status pN0/pN1 will be included in the study. The study will collect clinical-pathological, genomic characteristics, adjuvant treatments (chemotherapy, endocrine therapy with/without OFS), and survival outcome (iDFS).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- — 至 60 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female, premenopausal and ≥18 years age patients.
- •Agree to participate in study and signing informed consent or declaration in lieu of informed consent form, if applicable
- •Histological diagnosis of early breast cancer hormone positive (ER and/or PgR), HER2-negative.
- •Pathological nodal stage of pN0 or pN1 (1-3 nodes) and pathological tumor stage of pT1 to pT
- •Surgery for primary breast cancer and axillary staging by sentinel node biopsy or axillary lymph node dissection (ALND).
- •Availability of 21-multigene assay Oncotype DX recurrence score results performed according to physician choice from 1st January 2013 to 31st December 2022
- •Availability of clinical and pathological information.
- •Availability of information about adjuvant treatment received.
- •Availability of patient' outcome information (relapse, site of relapse, survival).
排除标准
- •Evidence of distant metastases
- •Inflammatory breast cancer
- •Neoadjuvant treatment
- •No surgery for primary breast cancer and axillary staging
- •Patients not tested with 21-multigene assay Oncotype DX
研究组 & 干预措施
node negative (pN0)
Patients with node negative (pN0) diagnosis and availability of Recurrence Score at Oncotype Dx test
node positive (pN1)
Patients with node positive (pN1) diagnosis and availability of Recurrence Score at Oncotype Dx test
结局指标
主要结局
Invasive Disease-Free Survival (iDFS) at 5 years
时间窗: up to 30 months
The primary endpoint of the study will be the invasive Disease-Free Survival (iDFS) at 5 years among pN0 and pN1 premenopausal breast cancer patients in subgroups formed according to their genomic risk according to 21- multigene assay Oncotype DX.
次要结局
- To describe the effect of the different adjuvant treatments according to clinical and genomic risk(up to 30 months)