EUCTR2015-004231-12-NL进行中（未招募）1 期
Early identification of patients who benefit from palbociclib in addition to letrozole
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- •1.Patients with ER positive (i.e. >1% staining), HER2 negative metastatic breast cancer (preferably assessment on fresh metastasis biopsy, alternatively archival metastasis biopsy)
- •2.Post-menopausal status defined as:
- •a.Age =60 years
- •b.Previous bilateral oophorectomy
- •c.Age <60 years and amenorrhea for >12 months in the absence of interfering hormonal therapies (such as LH-RH agonists and ER-antagonists
- •d.Age <60 years using ER antagonists should have amenorrhea for >12 months and FSH >24U/L and LH>14U/L
- •3.Adequate bone marrow and organ function defined as follows:
- •a.Absolute neutrophil count > 1.5 x 109/L
- •b.Platelet count >100 x 109/L
- •c. White blood cell count >3 x 109/L
- •d.AST and ALT <3.0 x upper limit of normal (ULN) or <5 xULN in case of known liver metastases.
- •e.Alkaline phosphatase <2.5 x ULN
- •f.Total serum bilirubin < ULN or total bilirubin <3.0 x ULN with direct bilirubin within normal range in patients with Gilbert’s Syndrome
- •g.Creatinine clearance >30mL/min
- •h.Lipase/amylase <1/5 x ULN
- •i.Protrombin time, partial tromboplastin time and INR <1.5 x ULN
- •4.ECOG performance 0-2
- •5.Signed written informed consent
- •6.Able to comply with the protocol
- •7.Age =18 years
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •A potential subject who meets any of the following criteria will be excluded from participation in this study:
- •1.Life expectancy < 3 months
- •2.Evidence of central nervous system metastases
- •3.Presence of life-threatening visceral metastases
- •4.Prior use of CDK4/6 inhibitor
- •5.Use of estrogen receptor ligands including estrogens, fulvestrant or tamoxifen <6 weeks before study entry.
- •6. Use of other anticancer therapy < 2 weeks prior to start with palbociclib
- •7.Concurrent malignancy
- •8.Active cardiac disease or a history of cardiac dysfunction
研究者
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