Association of Survival With Maintenance Therapy in Patients With Metastatic Breast Cancer After First-line Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 760
- 试验地点
- 3
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
To investigate the benefits and risks of maintenance chemotherapy (MCT), maintenance endocrine therapy (MET) and none maintenance therapy after first-line treatment of metastatic breast cancer (MBC).
详细描述
There are several options for MBC patients who are responding to chemotherapy, to continue treatment with a fix number of cycles or until disease progression which also known as maintenance chemotherapy (MCT), to stop chemotherapy and take a watch and wait strategy, or to stop chemotherapy and start the maintenance endocrine therapy (MET) for hormone receptor (HR) positive patients. Since the role of maintenance therapy in prolonging the overall survival (OS) and progression-free survival (PFS) of MBC was controversial in previous studies, the investigators performed a systematic review of randomized controlled trials to detect the association of survival with maintenance therapy in patients with MBC after first-line chemotherapy. And the investigators further performed a multi-center retrospective real-world study to evaluate these two maintenance modalities.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with pathologically clear invasive breast cancer between 2003 and 2018;
- •Female,18-75 years old;
- •Measurable metastatic lesion according to RECIST 1.1 evaluation criteria;
- •The first-line chemotherapy regimen is a breast cancer combination or single-agent chemotherapy regimen recommended by the NCCN guidelines;
- •First-line chemotherapy is effective (according to RECIST1.1 evaluation criteria, the efficacy is evaluated as complete response (CR), partial response (PR), or steady state (SD));
- •After the last cycle of first-line chemotherapy, patients should still be in a state of no progress for at least 4 weeks;
- •Patients' Karnofsky performance status (KPS) scores were ≥70.
排除标准
- •Unmeasurable metastatic lesion according to RECIST 1.1 evaluation criteria.
研究组 & 干预措施
MCT Group
People who received chemotherapy as a maintenance therapy after first-line chemotherapy reaching a state of no progress for at least 4 weeks. One patient only received one of the intervention drugs for maintenance therapy.
干预措施: Capecitabine (Drug)
MCT Group
People who received chemotherapy as a maintenance therapy after first-line chemotherapy reaching a state of no progress for at least 4 weeks. One patient only received one of the intervention drugs for maintenance therapy.
干预措施: Liposomal doxorubicin (Drug)
MCT Group
People who received chemotherapy as a maintenance therapy after first-line chemotherapy reaching a state of no progress for at least 4 weeks. One patient only received one of the intervention drugs for maintenance therapy.
干预措施: Gemcitabine (Drug)
MET Group
People who received endocrine therapy as a maintenance therapy after first-line chemotherapy reaching a state of no progress for at least 4 weeks. One patient only received one of the intervention drugs for maintenance therapy.
干预措施: Fulvestrant (Drug)
MET Group
People who received endocrine therapy as a maintenance therapy after first-line chemotherapy reaching a state of no progress for at least 4 weeks. One patient only received one of the intervention drugs for maintenance therapy.
干预措施: Anastrozole (Drug)
MET Group
People who received endocrine therapy as a maintenance therapy after first-line chemotherapy reaching a state of no progress for at least 4 weeks. One patient only received one of the intervention drugs for maintenance therapy.
干预措施: Letrozole (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: Estimated 36 months
From enrollment to death (for any reason)
次要结局
- Progression free survival (PFS)(Estimated 18 months)
研究者
Herui Yao
Principal Investigator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University