Comparative Effectiveness of Palbociclib Plus Aromatase Inhibitor Versus Fulvestrant Alone as Initial Endocrine Therapy for HR+/HER2- Advanced Breast Cancer in Chinese Clinical Practice: a Real-world Study
试验速览
- 阶段
- 不适用
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Real-world progression-free survival (rwPFS)
研究概览
简要总结
A retrospective cohort study conducted at the Cancer Hospital Chinese Academy of Medical Sciences to compare the effectiveness of palbociclib plus AI therapy and fulvestrant monotherapy as initial endocrine therapy in the patients with HR+/HER2- advanced breast cancer.
详细描述
This study is designed to be a retrospective cohort study conducted at the Cancer Hospital Chinese Academy of Medical Sciences. The target populations of this study are patients with HR+/HER2- advanced breast cancer who received the initial endocrine therapy of palbociclib plus AI or fulvestrant monotherapy from August 1, 2018 to December 31, 2020. It is expected to enroll 600 subjects in this study. The subjects' data such as demographics and other baseline characteristics, medications, prognosis, will be collected retrospectively, and statistical analysis of data will be conducted to compare the effectiveness outcome measures.
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 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Chinese women ≥18 years old;
- •Diagnosed with locally advanced (stage IIIb/IIIc) or metastatic (stage IV) breast cancer;
- •The molecular classification is pathologically confirmed as HR+/HER2-;
- •Palbociclib plus AI or fulvestrant monotherapy as initial endocrine therapy for advanced breast cancer for at least 1 cycle;
- •The follow-up time should be not less than 3 months after the start of palbociclib plus AI therapy or fulvestrant monotherapy.
排除标准
- •Subjects who have previously received chemotherapy, other CDK4/6 inhibitors or other endocrine monotherapy for advanced breast cancer.
研究组 & 干预措施
palbociclib + aromatase inhibitor
Adult patients with HR+/HER2- advanced breast cancer who received the initial endocrine therapy of palbociclib plus aromatase inhibitor at the Cancer Hospital Chinese Academy of Medical Sciences from August 1, 2018 to December 31, 2020.
干预措施: palbociclib + aromatase inhibitor (Drug)
fulvestrant
Adult patients with HR+/HER2- advanced breast cancer who received the initial endocrine therapy of fulvestrant monotherapy at the Cancer Hospital Chinese Academy of Medical Sciences from August 1, 2018 to December 31, 2020.
干预措施: fulvestrant (Drug)
结局指标
主要结局
Real-world progression-free survival (rwPFS)
时间窗: From date of index treatment to death, disease progression, or end of study, whichever came first, assessed up to 36 months.
It is defined as the time (months) from the start of palbociclib+AI or fulvestrant monotherapy to progressive disease or all-cause mortality. The progressive disease is determined by clinicians based on the results of clinical evaluation, laboratory tests, imaging or pathological examinations. Patients who have not died or have not experienced progressive disease will be censored at the beginning of next-line treatment or at the last visit during the study period.
次要结局
- Overall survival(From date of index treatment until date of death from any acuse or date of end of study, whichever came first, assessed up to 36 months.)
- Real-world tumor response (rwTR)(From date of index treatment to death, disease progression, or end of study, whichever came first, assessed up to 36 months.)
研究者
Peng Yuan
Professor
Chinese Academy of Medical Sciences
