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临床试验/NL-OMON46198
NL-OMON46198已完成2 期

Early identification of patients who benefit from palbociclib in addition to letrozole - Palbociclib and FES PET

niversitair Medisch Centrum Groningen0 个研究点目标入组 30 人开始时间: 待定最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
30

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 99(—)

入选标准

  • 1. Patients with ER positive (i.e. >1% staining), HER2 negative metastatic breast cancer
  • 2. Post-menopausal status
  • 3. Adequate bone marrow and organ function
  • 4. ECOG performance 0-2
  • 5. Signed written informed consent
  • 6. Able to comply with the protocol
  • 7. Age >=18 years

排除标准

  • 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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