Prospective Study Evaluating the Probability of OncotypeDx to Allocate At Low or High Risk of Recurrence Early ER Positive HER2 Negative Breast Cancer Patients with Uncertain Biological Behavior Evaluated by Pathological Parameters
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 258
- 试验地点
- 1
- 主要终点
- the proportion of tumor samples with a useful OncotypeDx
研究概览
简要总结
In some cases of hormone receptor positive, human epidermal growth factor receptor 2 (HER2) negative early breast cancer the benefit of adding adjuvant chemotherapy to hormonal treatment, estimated on the basis of the classical clinico-pathological parameters, is unclear. In these cases the application of a genomic test could be useful in guiding the therapeutic choice.
详细描述
Oncotype Dx (ODx) is a 21-gene assay that classifies primary ER+ breast tumors into three categories of recurrence risk: High (HR), Intermediate (IR) and Low (LR).
Available data show that
- patients with ODx low score breast cancer perform well without chemotherapy,
- chemotherapy has an additive value to endocrine therapy in patients with ODx high score tumors, and
- the role of chemotherapy is unknown in patients with ODx intermediate score cancer.
In this study, the investigators aim to evaluate the capability of ODx to help in guiding the choice of systemic adjuvant treatment in a group of patients with ER+ and HER2- , node negative (pN0) or micrometastatic (pNmi) breast cancer with uncertain biological behavior for whom there is uncertainty about the indication of adjuvant chemotherapy.
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
- •Histological diagnosis of infiltrating ductal or lobular ER+ HER2- early breast cancer adequately treated with surgery
- •Nodal status: no regional lymph node metastasis (pN0) or micrometastatic regional lymph node (pN1mic)
- •Uncertain biological behavior defined by all of the following parameters: ER >20% and progesterone receptor (PgR) >20% and Ki67 between 14% and 30% and G2
- •Written informed consent
排除标准
- •pathologic tumor stage (pT) > 5 cm (not applicable to the internal control group)
- •Prior neoadjuvant therapy
- •Evidence of metastatic disease
- •No axillary exploration (sentinel lymph node biopsy or axillary dissection)
- •Multifocal or multicentral or bilateral tumors
结局指标
主要结局
the proportion of tumor samples with a useful OncotypeDx
时间窗: 15 days
number of low risk and high risk at OncotypeDx divided by the total number of tests
次要结局
- the proportion of patients in which the result of the test has induced a modification in the initial treatment plan(15 days)
- the proportion of tumor samples with an intermediate risk or not evaluable at OncotypeDx(15 days)