A Cohort Study of Different Methods of Adjuvant Capecitabine Regimens in Patients With Non-PCR After Neoadjuvant Therapy for Triple Negative Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,166
- 试验地点
- 1
- 主要终点
- disease free survival
研究概览
简要总结
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 patients. Therefore, studies have confirmed that intensive adjuvant therapy for patients with non-pCR after neoadjuvant chemotherapy can further improve the survival of this population. Previous studies have given capecitabine treatment to such patients as standard. However, it is unknown whether capecitabine intensification still has the same status under the premise that most patients receive immunotherapy at the neoadjuvant stage; Whether there are differences in the efficacy and safety of capecitabine standard 6-8 cycle intensive regimen and capecitabine metronomic chemotherapy are practical problems encountered in clinical practice. This study explored the efficacy and safety of 6-8 cycles of full dose capecitabine intensive therapy compared with 1-year capecitabine metronomic chemotherapy in patients with T2 and above and/or lymph node positive early triple negative breast cancer who still had invasive tumor after neoadjuvant therapy.
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 triple negative breast cancer 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;
- •Neoadjuvant chemotherapy is unlimited, and immunotherapy is allowed in neoadjuvant and/or adjuvant treatment;
- •Postoperative pathology confirmed the presence of residual invasive breast cancer in the breast and/or 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;
- •BRCA has pathogenic or possibly pathogenic mutations, and received intensive treatment with PARP inhibitors after operation
研究组 & 干预措施
6-8 cycles full dose capecitabine
6-8 cycles of full dose capecitabine intensive therapy (1250mg/m2, BID,D1-D14,Q3W)
干预措施: capecitabine (Drug)
1-year metronomic capecitabine
1-year capecitabine metronomic chemotherapy (650mg/m2,BID)
干预措施: capecitabine (Drug)
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