Prospective Assessment of Disease Progression in Primary Breast Cancer Patients Undergoing EndoPredict® Gene Expression Testing - a Care Research Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 1,191
- 试验地点
- 72
- 主要终点
- Distant metastasis free survival
研究概览
简要总结
Systematic assessment of survival data of patients who have been tested with EndoPredict®; prospective proof that patients with low risk classification by EndoPredict® (EPclin) can safely forgo chemotherapy and be treated with endocrine therapy alone.
详细描述
The goal of the study is to receive current and comprehensive information about the diseasefree (remote metastasis free and recurrence free) interval of EndoPredict® low risk patients.
The study is organized and managed by the NOGGO e.V. (North Eastern German Society of Gynaecological Oncology e.V.) study coordination office under the existing and efficient infrastructure. All patients who receive gene expression analysis with EndoPredict® and satisfy the remaining inclusion / exclusion criteria may participate in the study. Data collection is prospective and non-interventional. The recruitment of the required patients is expected to take a maximum of 36 months .
It must be emphasized that the study is data collection only and not an interventional study. This means that the choice and implementation of the therapy as well as the treatment assessments and frequency during and after the treatment can only be determined by the Investigator.
The decision to participate in the study is independent of the patient´s therapy within the framework of a study. Patient data will be recorded at the time of inclusion and once a year thereafter. Patient follow-up will be by phone from the second year onward.
Primary objective is to show that female patients who have been tested as "low risk" by EPclin and have been treated with endocrine therapy only for at least 5 years have a 10-year DMFS rate > 90% (lower boundary of the one-sided 95% confidence interval).
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
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent
- •Tested with EndoPredict within the previous 6 months before inclusion
- •Age ≥ 18 years
- •Patients with primary invasive breast cancer, Stage I/II
- •ER-positive
- •HER2-negative
- •N0 or N1 (1-3 positive lymph nodes)
排除标准
- •Inflammatory breast cancer
- •Bilateral breast cancer
- •Breast cancer in the last 10 years
- •Other invasive malignancies in the last 5 years
研究组 & 干预措施
Observational Group
Patients with primary invasive breast cancer, Stage I/II; ER positive, HER2 (human epidermal growth factor receptor 2) negative, N0-N1, T1-T3, tested with EndoPredict®, age over 18 years, informed consent
干预措施: Observation (Other)
结局指标
主要结局
Distant metastasis free survival
时间窗: 10 years
To show that female patients who have been tested as "low risk" by EndoPredict® (EPclin) and have been treated with endocrine therapy only for at least 5 years have a 10-year distant metastasis-free survival (DMFS) \> 90 % (lower boundary of the one-sided 95 % confidence interval)
次要结局
- Duration of endocrine therapy(10 years)
- OS "high risk + low risk"(3, 5 and 10 years)
- DFS "low risk vs. high risk"(3, 5 and 10 years)
- OS of patient proportion of EPclin low and high risk patients in Ki67 low, intermediate and high tumors(3, 5 and 10 years)
- Chemotherapy regimens(1 year)
- DFS "high risk"(3, 5 and 10 years)
- OS "high risk"(3, 5 and 10 years)
- DMFS "high risk + low risk"(3, 5 and 10 years)
- DFS for patients with 5 years of endocrine therapy vs. extended endocrine therapy(10 years)
- Correlation ( pT- and pN data vs. ciT and ciN-data)(1 year)
- DMFS "low risk"(3, 5 and 10 years)
- DFS "low risk"(3, 5 and 10 years)
- DMFS "high risk"(3, 5 and 10 years)
- OS "low risk"(3, 5 and 10 years)
- DMFS "low risk vs. high risk"(3, 5 and 10 years)
- DMFS "low risk vs. high risk" who have /have not been treated according to the S3 and St. Gallen guidelines(3, 5 and 10 years)
- DFS "high risk + low risk"(3, 5 and 10 years)
- Prognostic Performance of classical prognostic factors compared to EndoPredict®(3, 5 and 10 years)
- OS "low risk vs. high risk"(3, 5 and 10 years)
- DFS "low risk vs. high risk" who have /have not been treated according to the S3 and St. Gallen guidelines(3, 5 and 10 years)
- Portion of patients tumor board follows the EndoPredict® result(1 year)
- Portion of patient treated according EndoPredict® result(1 year)
- DMFS of patient proportion of EPclin low and high risk patients in Ki67 low, intermediate and high tumors(3, 5 and 10 years)
- DFS of patient proportion of EPclin low and high risk patients in Ki67 low, intermediate and high tumors(3, 5 and 10 years)
- DMFS for patients with 5 years of endocrine therapy vs. extended endocrine therapy(10 years)
- OS for patients with 5 years of endocrine therapy vs. extended endocrine therapy(10 years)
- OS "low risk vs. high risk" who have /have not been treated according to the S3 and St. Gallen guidelines(3, 5 and 10 years)
- Given endocrine therapy(10 years)
- Concordance ( pT- and pN data vs. ciT and ciN-data)(1 year)
- Proportion of patients with prolonged endocrine therapy(10 years)