Retrospective Observational Analysis of Palbociclib Treatment in Patients With Advanced Breast Cancer Within a Compassionate Use Programme
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 237
- 试验地点
- 1
- 主要终点
- Time to progression
研究概览
简要总结
In Spain, palbociclib was launched last November 1st, 2017. However, since February 2015 the on-going compassionate use programme of palbociclib has enabled drug access to patients with RH+/HER2- breast cancer previously treated with at least 4 treatment lines for advanced disease. During this period, approximately 400 patients have received treatment within this programme. Since this population of patients more pre-treated was not included in the studies for regulatory submission, the collection of efficacy and toxicity data 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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with RH+ y HER2- metastatic breast cancer having progressed to at least 4 previous standard treatment lines in the metastatic setting, and are not eligible to receive palbociclib in a clinical trial
- •Absolute neutrophil count ≥1,500/mm3 (1.5 x 109/L)
- •Platelet count ≥100,000/mm3 (100 x 109/L)
- •Haemoglobin ≥9 g/dL
- •Creatinine ≤1.5 x ULN or creatinine clearance ≥ 60 mL/min
- •Total bilirubin ≤1.5 x ULN (≤3.0 x ULN in case of Gilbert's disease)
- •AST and/or ALT ≤3 x ULN (≤5.0 x ULN in case of hepatic metastases)
- •Alkaline phosphatase ≤2.5 x ULN (≤5.0 x ULN in case of hepatic or bone metastases)
排除标准
- •Major surgery, chemotherapy, radiotherapy, treatment with an investigational drug or any other active anticancer therapy within two weeks of treatment initiation
- •Previous radiotherapy in ≥25% of bone marrow
- •QTc >480 msec, personal or family past history of short or long QT syndrome, Brugada's syndrome, or past history of QT interval prolongation, or tachycardia with Torsade de Pointes (TdP)
- •History of any of the following conditions within 6 months of treatment initiation: myocardial infarction, unstable angina, grade ≥2 arrhythmia (CTCAE version 4.0), atrial fibrillation, coronary or peripheral artery by-pass, symptomatic congestive heart failure, stroke, or pulmonary thromboembolism
- •Known hypersensitivity to palbociclib
- •Current or recent suicidal ideation or behaviour
研究组 & 干预措施
Palbociclib treatment
干预措施: Palbociclib (Drug)
结局指标
主要结局
Time to progression
时间窗: through study completion, up to 9 months
Number of days between the beginning of the treatment with palbociclib and the progression
次要结局
- Number of adverse events(through study completion, up to 9 months)
研究者
Fernando Moreno Antón
Principal Investigator
Hospital San Carlos, Madrid