A Cohort Study of Different Choice of Adjuvant Therapy in Non-PCR Patients With HER2 Positive Early Breast Cancer After Neoadjuvant Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,092
- 试验地点
- 1
- 主要终点
- invasive disease free survival
研究概览
简要总结
Chemotherapy combined with trastuzumab and patuzumab is the standard neoadjuvant therapy for HER2 positive breast cancer patients. The survival rate of patients with pathological complete response (PCR) after neoadjuvant therapy was significantly better than that of patients with tumor residue, that is, non-PCR. Therefore, studies have confirmed that adjuvant therapy for patients with non-PCR after neoadjuvant chemotherapy can further improve the prognosis and survival of this population. However, the results of previous studies are based on trastuzumab target therapy in neoadjuvant therapy. Therefore, there are different recommendations for the current guidelines of adjuvant therapy after trastuzumab combined pertuzumab target neoadjuvant therapy. Patients with HER2 positive breast cancer who received trastuzumab and patuzumab based neoadjuvant therapy had invasive residual cancer in postoperative pathology. The effect of postoperative adjuvant therapy with trastuzumab and patuzumab or replacement of T-DM1 on survival.
详细描述
Investigators retrospectively recruited patients with HER2 positive breast cancer who received trastuzumab and patuzumab based neoadjuvant therapy had invasive residual cancer in postoperative pathology from January 1, 2019 to November 31, 2024, and prospectively recruit patients of the same type from December 1, 2024 to December 31, 2028.
Inclusion Criteria:
- Patients with HER2 positive breast cancer were diagnosed by biopsy in Peking University People's hospital;
- The clinical stages before treatment were T1-T4, N0-N3, M0;
- Received treatment and operation in our hospital, and had hospitalization records;
- Receive at least 4 cycles of trastuzumab and pertuzumab target therapy combined chemotherapy as neoadjuvant therapy
- Postoperative pathology confirmed the presence of residual invasive breast cancer in the breast and/or metastatic tumor lesions in axillary lymph nodes;
- 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;
- Receiving other regimens besides the established neoadjuvant regimens.
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 were diagnosed by biopsy in Peking University People's hospital;
- •The clinical stages before treatment were T1-T4, N0-N3, M0;
- •Received treatment and operation in our hospital, and had hospitalization records;
- •Receive at least 4 cycles of trastuzumab and pertuzumab target therapy combined chemotherapy as neoadjuvant therapy
- •Postoperative pathology confirmed the presence of residual invasive breast cancer in the breast and/or metastatic tumor lesions in axillary lymph nodes;
- •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;
- •Receiving other regimens besides the established neoadjuvant regimens.
结局指标
主要结局
invasive disease free survival
时间窗: 3 years
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(3 years)
- distant disease free survival(3 years)
- breast cancer specific survival(3 years)
- overall survival(3 years)
研究者
Shu Wang
director of breast center
Peking University People's Hospital