NCT04972448尚未招募不适用
A Clinical Translational Study on the Multi-gene Assays and RecurIndex for Predicting the Breast Cancer Recurrence Risk in Cross-strait Chinese Patients With Early-stage Luminal Breast Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 500
- 主要终点
- invasive disease-free survival (IDFS)
研究概览
简要总结
This study will conduct a multicenter, open, prospective clinical trial to observe the RecurIndex to assist in predicting the risk of recurrence in patients with early-stage Luminal-type breast cancer. The aim of this study is to validate the predictive effect of the RecurIndex on the risk of recurrence in women with early-stage Luminal-type breast cancer in China.
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old, ≤ 70 years old.
- •Eastern Cooperative Oncology Group (ECOG) ≤
- •Postoperative pathology is clearly diagnosed as invasive breast cancer.
- •Estrogen receptor (ER) or progesterone receptor (PR) positive, HER2 negative.
- •Available with Formalin-Fixed and Parrffin-Embedded (FFPE) tumor tissue.
- •Stage I-II patients who have received surgery (breast-conserving or mastectomy) and the pathological staging is pT1-2N0-1M0 or pT3N0M
- •The patient had not received systemic systemic treatment (including radiotherapy, chemotherapy, immunotherapy, endocrine therapy) before enrollment.
- •Signed an informed consent form.
排除标准
- •Breast cancer patients whose clinical or pathological stage is T4, N2-3 or M
- •Known human immunodeficiency virus infection (HIV) or acquired immunodeficiency syndrome (AIDS) related diseases.
- •Other psychiatric disorders that may interfere with the judgment of the study results, or abnormal laboratory tests; and who, in the judgment of the investigator, are considered unfit to participate in the study.
- •Patients with double breast cancer.
- •Severe/uncontrolled intercurrent diseases/infections.
- •Subjects with allogeneic organ transplants requiring immunosuppressive therapy.
- •Hormone receptors ER and PR are negative (any detectable estrogen and progesterone receptors do not express or express <1%) and/or HER2 overexpression/amplified by FISH detection.
- •Not suitable for hormone receptor modulators (e.g. tamoxifen) and adjuvant endocrine other drug therapy.
结局指标
主要结局
invasive disease-free survival (IDFS)
时间窗: 5 years
defined as time between treatment and the time of invasive disease occurred
recurrence free survival (RFS)
时间窗: 5 years
defined as time between treatment and the time of any recurrence of ipsilateral chest, breast, regional lymph node recurrence, distant metastases, or death occurred
次要结局
- distance metastasis-free interval (DMFI)(5 years)
- local-regional recurrence-free interval (LRFI)(5 years)
- overall survival (OS)(5 years)
研究者
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