Cohort Study of Chemotherapy Combined With Targeted Adjuvant Therapy for High-risk HER2 Positive and Lymph Node Negative Early Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,916
- 试验地点
- 1
- 主要终点
- disease free survival
研究概览
简要总结
Human epidermal growth factor receptor 2 (HER2) positive breast cancer is a molecular subtype with high malignancy and easy recurrence and metastasis. The emergence of HER2 targeted drugs has greatly improved the prognosis and survival of such patients. At present, for HER2 positive breast cancer patients with negative lymph nodes, chemotherapy drugs combined with trastuzumab is the current standard treatment scheme, and in most cases, chemotherapy uses a combination of two drugs, while the main beneficiaries of the target treatment of trastuzumab and pertuzumab are concentrated in the group of patients with positive lymph nodes. Can the use of target therapy to de-escalation chemotherapy and further achieve a strategy of high efficacy and low toxicity. It is planned to explore the efficacy and safety of T1-T2, HER2 positive early breast cancer patients with negative lymph nodes to achieve chemotherapy reduction based on risk stratification.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Treated in Peking University People's Hospital and underwent radical resection with hospitalization records;
- •Postoperative pathology confirmed invasive breast cancer, pathological staging was T2, N0, HER2 positive, and accompanied by one of the high-risk factors (G3, or hormone receptor negative);
- •Has signed and agreed to participate in the PKUPH breast disease cohort study.
排除标准
- •Lack of clinical and pathological data (such as imaging data and pathological data);
- •Preoperative neoadjuvant therapy;
- •Patients with metastatic breast cancer or bilateral breast cancer;
- •Failure to perform radical surgery.
结局指标
主要结局
disease free survival
时间窗: 5 years
The time from study enrollment to the first occurrence of the following events defined as failure, including ipsilateral local recurrence, contralateral breast cancer, distant recurrence or death from any cause.
次要结局
- invasive disease free survival(5 years)
- distant disease free survival(5 years)
- breast cancer specific survival(5 years)
- overall survival(5 years)
研究者
Shu Wang
director of breast center
Peking University People's Hospital