Adopting the MRD Strategy to Optimize Post-operation Adjuvant Therapies for Early Stage Breast Cancer, a Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 3
- 主要终点
- 3 years disease free survival(DFS)
研究概览
简要总结
This study is a prospective, multi-center, open-label cohort study, with 3 years disease free survival(DFS) as the primary endpoint. We optimize post-operation adjuvant therapy for early stage breast cancer based on the MRD strategy: patients with clinical high risk or post-operation 1st MRD tested positive will receive intensive adjuvant therapy, while patients with low clinical risk and post-operation 1st MRD tested negative will receive standard adjuvant therapy, and the treatment regimens will be adjusted every 3 months according to the change of MRD status. About 100 TNBC patients, 100 HER2+ patients, and 100 ER+ patients are planned to be enrolled.
详细描述
MRD will be tested with tumor-informed personalized panel in this trail. The adjuvant therapies in the MRD strategy are all standard therapies in guidelines of China or abroad.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subjects aged ≥18 years (inclusive).
- •Histologically confirmed, perioperative invasive breast cancer that is resectable without metastasis(stage I-III).
- •No anti-breast cancer systematic therapy received, and planning to receive surgery and systemic therapy.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-
- •With Adequate Organ Function:
- •a. Bone marrow function: Hemoglobin ≥ 10 g/dL; Absolute leucocyte count ≥ 4×10^9/L; Absolute neutrophil count ≥ 1.5×10^9/L; Platelets ≥ 100 × 10^9/L; b. Liver function (based on the normal values specified by study site): Serum total bilirubin ≤ 1.5 × the upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; c. Renal function (based on the normal values specified by study site): Serum creatinine ≤ 1.5 × ULN.
- •The patients voluntarily signed an informed consent form.
排除标准
- •Known to have other aggressive malignant tumor that is progressing or requires systemic treatment in the past 5 years (does not exclude subjects with skin basal cell carcinoma, skin squamous cell carcinoma, breast ductal carcinoma in situ or cervical cancer in situ that has received curative treatment).
- •Have a clear history of neurological or mental disorders, including epilepsy or dementia, etc.; have a history of psychotropic drug abuse or drug abuse.
- •Known history of allergy to the drug components in MRD strategy; history of immunodeficiency, or history of organ transplantation.
- •There are other concomitant diseases that seriously threaten the patient's safety or affect the patient's completion of the study, such as serious infection, liver disease, cardiovascular disease, kidney disease, respiratory disease or uncontrolled diabetes or dyslipidemia.
- •Female patients during pregnancy or lactation.
- •The investigator determines that subjects are not appropriate to participate in the study due to other factors.
结局指标
主要结局
3 years disease free survival(DFS)
时间窗: From date of radical surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
the period after curative treatment \[disease eliminated\] when no disease can be detected
次要结局
- Adverse events (AEs)(Up to 5 years)
- 1 years disease free survival(DFS)(From date of radical surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months)
- 5 years disease free survival(DFS)(From date of radical surgery until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months)
- Overall Survival(OS)(From date of radical surgery until the date of death from any cause, assessed up to 60 months)
- quality of life (QoL)(Up to 5 years)
研究者
Ma Fei，MD
Deputy Director of Medical Oncology
Cancer Institute and Hospital, Chinese Academy of Medical Sciences