Impact of Recurrence Score on Adjuvant Treatment Decisions and Tumor Cell Dissemination in Estrogen-receptor Positive and HER2 Negative Patients With Early Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- Evaluation of the influence of the 21-gene Recurrence-Score (RS) on adjuvant therapy recommendation
研究概览
简要总结
IRMA is a Prospective, monocenter, non-interventional investigator initiated (IIT) registry that aims to investigate the use of the CE-marked OncotypeDX and its impact on adjuvant therapy recommendations in the clinical routine. Additionally, the proportion of patients with low, intermediate and high RS in predefined clinical subgroups will be determined. To evaluate the impact of the RS on tumor cell dissemination, these subgroups also include DTC-negative versus DTC-positive patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •women ≥ 18 years of age
- •histologically proven unilateral primary non-metastatic invasive breast cancer
- •ER-/ or PR- positive and HER2-negative
- •N0-N1 (0-3 involved lymph-nodes). The nodal status may be evaluated clinically.
- •surgery or planed surgery at the Department of women's health, Tuebingen
- •written informed consent into IRMA
排除标准
- •ER-negative
- •HER2-positive
- •> 3 involved lymph-nodes
- •bilateral breast cancer
- •preexisting cancer disease within the last 10 years
- •preexisting invasive ipsi- or contralateral breast cancer (non-invasive ipsi- or contralateral breast cancer is not regarded as an exclusion criteria)
- •primary systemic therapy
- •locally advanced, inoperable or metastatic breast cancer
- •pregnant or lactating patients
- •inadequate general condition (not fit for chemotherapy)
结局指标
主要结局
Evaluation of the influence of the 21-gene Recurrence-Score (RS) on adjuvant therapy recommendation
时间窗: 1 year
The Recurrence Score is a continuous score that provides an individual estimate of the 10 year risk of distant recurrence and predicts the likelihood of benefit from chemotherapy. The quantitative nature of PCR allows for a continuous score as opposed to a binary result (low vs. high only). Oncotype DX test results assign a Recurrence Score - a number between 0 and 100 - to the early-stage breast cancer or DCIS. Recurrence Score lower than 18: The cancer has a low risk of recurrence. The benefit of chemotherapy is likely to be small and will not outweigh the risks of side effects. Recurrence Score of 18 up to and including 30: The cancer has an intermediate risk of recurrence. It's unclear whether the benefits of chemotherapy outweigh the risks of side effects. Recurrence Score greater than or equal to 31: The cancer has a high risk of recurrence, and the benefits of chemotherapy are likely to be greater than the risks of side effects.
次要结局
- Correlation of the RS with tumor grading(1 year)
- Correlation of the RS with tumor nodal status(1 year)
- Evaluation of the association of the RS with tumor cell dissemination into bone marrow(1 year)
- Correlation of the RS with age(1 year)
- Correlation of the RS with proliferation marker Ki-67(1 year)