NCT03535506终止2 期
Preoperative Palbociclib in Patients With DCIS of the Breast That Are Candidates for Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Feasibility: Recruitment Rates
研究概览
简要总结
This is a feasibility study which will evaluate the effects of pre-operative treatment of DCIS of the breast with palbociclib. Patients with biopsy-proven DCIS are eligible for the study.
There will be 2 independent and unrelated study groups of 12 patients each, for a total of 24 patients:
- Group A, of male or female patients treated with palbociclib single agent (n=12);
- Group B, untreated, of male or female patients who consented translational studies in blood, as well as diagnostic and definitive surgical specimen, but not the pre-operative treatment with palbociclib (n=12).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Group A
Experimental
Patients enrolled to Group A will receive a 12-day course of Palbociclib before surgery. They will receive Palbociclib 100mg PO daily x 12 days.
干预措施: Palbociclib (Drug)
结局指标
主要结局
Feasibility: Recruitment Rates
时间窗: 5 years
The approach will be considered feasible if more than 50% of the enrolled patients are treated andcomplete the study.
次要结局
- Pathologic Changes(2 months)
- Pathology Changes on Immunohistochemistry (IHC)(2 months)
- Toxcity Based on CTCAE(3 months)
研究者
研究点 (2)
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