Observational Analysis of Treatment With Palbociclib in Patients With Locally Advanced and / or Metastatic RH + / HER 2- Breast Cancer in the First Line of Treatment Within Routine Clinical Practice.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 815
- 试验地点
- 36
- 主要终点
- Real-world progression free survival (rwPFS)
研究概览
简要总结
Hormone therapy is the primary treatment option for patients with HR+ HER2- breast cancer. Despite its activity, hormone therapy is associated with initial, or more frequently acquired, resistance after exposure to one or more treatment lines.
The combination of palbociclib with hormone therapy significantly increases progression free survival (PFS) compared with hormone therapy in first and second treatment line of HR+ HER2- advanced breast cancer.
These results lead to palbociclib approval by the Food and Drug Administration (FDA) in February 2015, and European Medicines Agency (EMA) approval in November 2016 for first-line treatment of patients with metastatic HR+/HER2-breast cancer in combination with an aromatase inhibitor, and for patients who had previously received hormone therapy in combination with fulvestrant.
In Spain, palbociclib was launched last November 1st, 2017. During this period, approximately 3500 patients have received treatment with Palbociclib, and approximately a half of them in first-line treatment in combination with hormone therapy. The collection of efficacy and toxicity data in the first-line usage in the clinical practice setting is of clinical interest.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Documented histologically confirmed breast cancer with ER and/or PgR positive and HER2 negative status.
- •Locally advanced or metastatic breast cancer not deemed amenable to curative surgery or curative radiation therapy
- •HR+: ER+ or PR+ test before or up to 60 days after MBC diagnosis
- •HER2-: any HER2 negative test and the absence of a positive test (IHC positive 3+, FISH positive/amplified, Positive NOS) before or up to 60 days after MBC diagnosis
- •Female or male patients > 18 years
- •Have received at least one dose of palbociclib
- •At least 2 document clinical visits
- •Treatment with palbociclib should have started from November 2017 to November 2019
- •Data from the clinical records should be available.
- •Patients must be able to understand and sign informed consent if alive.
排除标准
- •Previous treatment with hormonal therapy, targeted therapy or chemotherapy for metastatic disease. Previous anticancer treatment for early breast cancer are allowed.
- •Treatment with palbociclib in clinical trial or compassionate use programs
- •HER2 + (IHC 3+ or FISH +) tumors in the most recent or previous biopsies
- •HR negative tumors in the most recent biopsy
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 52 months
Median time (months) from index date to death, disease progression based on radiology, laboratory evidence, pathology, or clinical assessment until next line therapy, or end of the study, whichever came first, assessed up to 52 months
次要结局
- Overall Survival(Time Frame: From date of index treatment until date of death from any accuse or date of end of study, whichever came first, assessed up to 52 months)
- Real-world tumor response (rwTR)(From date of index treatment to date of disease progression, date of death, or end of study whichever came first, assessed up to 52 months)
- Time to first use of chemotherapy(From date of index treatment to date of first use of chemotherapy, date of death, or end of study, whichever came first, assessed up to 52 months)
- Time to next line of therapy(From date of index treatment to date of next line therapy, date of death, or end of study, whichever came first, assessed up to 52 months)
研究者
Fernando Moreno Antón
Principal Investigator
Hospital San Carlos, Madrid