A Cohort Study of Adjuvant Therapy With Naratinib in HER2 Positive Early Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,806
- 试验地点
- 1
- 主要终点
- invasive 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 high risk to recurrence and metastasis. After the appearance of anti-HER2 targeted drugs, the prognosis and survival of these patients were greatly improved. In addition to trastuzumab and pertuzumab, the use of tyrosine kinase inhibitor (TKI) can further improve the survival. The evidence of previous adjuvant TKI anti-HER2 therapy was mainly from ExteNET study. However, due to the limitations of the times, ExteNET research is based on the background of only trastuzumab targeted therapy. Nowadays, there is no evidence that trastuzumab combined patuzumab,use of T-DM1, followed by sequential neratinib can still obtain absolute benefits. Therefore, there is no standard for the use of neratinib in current clinical practice. Investigators want to explore, in the real world, the efficacy and safety of sequential use of naratinib in adjuvant therapy.
详细描述
Investigators retrospectively recuited patients with early HER2 positive breast cancer treated in Peking University People's Hospital center from January 1, 2019 to November 31, 2024, and prospectively recruit same patients from December 1, 2024 to December 31, 2028. To compare the efficacy and safety of sequential use of neratinib.
Inclusion Criteria:
- Patients with HER2 positive breast cancer who were diagnosed by core needle biopsy/operation in Peking University People's hospital;
- The patients were treated in Peking University People's Hospital and underwent radical resection with hospitalization records;
- Received standard anti-HER2 neoadjuvant/adjuvant therapy (trastuzumab, trastuzumab combined with pertuzumab, T-DM1)
- Has signed and agreed to participate in the PKUPH breast disease cohort study.
Exclusion Criteria:
- Lack of clinical and pathological data (such as imaging data and pathological data);
- Patients with metastatic breast cancer or bilateral breast cancer;
- Failure to perform radical surgery
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
- •Patients with HER2 positive breast cancer who were diagnosed by core needle biopsy/operation in Peking University People's hospital;
- •The patients were treated in our hospital and underwent radical resection with hospitalization records;
- •Received standard anti-HER2 neoadjuvant/adjuvant therapy (trastuzumab, trastuzumab combined with pertuzumab, T-DM1)
- •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);
- •Patients with metastatic breast cancer or bilateral breast cancer;
- •Failure to perform radical surgery
研究组 & 干预措施
neratinib
After standard anti-HER2 neoadjuvant/adjuvant therapy, sequential targeted therapy with neratinib for 1 year
干预措施: neratinib (Drug)
结局指标
主要结局
invasive disease free survival
时间窗: 5 years
The time from study enrollment to the first occurrence of the following events defined as failure: local recurrence of ipsilateral invasive breast cancer, contralateral invasive breast cancer, distant recurrence or death from any cause.
次要结局
- 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