Real-world Database Study to Observe Safety and Effectiveness of Ibrance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Number of participants with associated risk factors
研究概览
简要总结
The purpose of this real-world study is to look at breast cancer patients receiving Palbociclib using a large real-world database collected under real-world practice. This study also looks at the safety of Ibrance, including any side effects. Side effects are undesired effects of a medicine or other type of treatment.
This study will include the data of the following participants:
- Adult women (more than18 years of age) with at least one visit with a breast cancer
- Patients with locally advanced breast cancer or metastatic breast cancer with a staging classification of stage III, stage IV. Advanced cancer is a term that is often used to describe cancer that is unlikely to be cured. Metastatic cancer is the cancer which is spread from the place where it started to other places in the body.
- Patients with a laboratory test positive for hormone receptor and negative for HER2 before or up to 60 days after advanced/metastatic breast cancer diagnosis date.
- Patients who received at least one initial prescription of Ibrance following a diagnosis of advanced/metastatic breast cancer.
This study will look at the safety of palbociclib treatment by looking at the number and severity of the side effects.
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
- •Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
- •Adult women (≥ 18 years of age) with at least one visit with a breast cancer ICD10 diagnosis code (C50.x)
- •Patients with locally advanced breast cancer or metastatic breast cancer with a staging classification of stage III, stage IV (distant metastases).
- •Patients with a laboratory test positive for hormone receptor (HR) and negative for human epithelial growth factor receptor 2 (HER2) before or up to 60 days after advanced/metastatic breast cancer diagnosis date.
- •HR-positive is defined as any positive test for estrogen receptor or progesterone receptor.
- •HER2-negative is defined as any HER2-negative test and the absence of a positive test (immunohistochemistry positive (3+), fluorescence in situ hybridization positive/amplified).
- •Patients who received at least one initial prescription of Ibrance following a diagnosis of advanced/metastatic breast cancer
排除标准
- •Patients meeting any of the following criteria will not be included in the study:
- •Breast cancer with HR-negative and HER2-positive on laboratory testing.
- •More than a 90-day gap between breast cancer diagnosis date and next visit.
- •Patients who treated as off-label
研究组 & 干预措施
Ibrance (palbociclib)
Patients who received at least one initial prescription of Ibrance following a diagnosis of advanced/metastatic breast cancer
干预措施: Ibrance (Drug)
结局指标
主要结局
Number of participants with associated risk factors
时间窗: From index date to last dose plus 28 days. Index is defined as the date of first prescription of Ibrance on participants diagnosed between 29 Aug 2015 through 30 Sep 2023
Number of participants with adverse events that occur during treatment
时间窗: From index date to last dose plus 28 days. Index is defined as the date of first prescription of Ibrance on participants diagnosed between 29 Aug 2015 through 30 Sep 2023
次要结局
- Overall Survival (OS)(From baseline to the date of death or censoring date, whichever occurs first on participants diagnosed between 29 Aug 2015 through 30 Sep 2023)
- Real-World Tumor Response (rwTR)(From baseline to the date of death or censoring date, whichever occurs first on participants diagnosed between 29 Aug 2015 through 30 Sep 2023)