NCT02491983已完成2 期
A Randomized, Multicenter, Open-label, Phase II Trial to Evaluate the Efficacy and Safety of Palbociclib in Combination With Fulvestrant or Letrozole in Patients With HER2 Negative, ER+ Metastatic Breast Cancer
MedSIR2 个研究点 分布在 2 个国家目标入组 486 人开始时间: 2015年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 486
- 试验地点
- 2
- 主要终点
- 1-year Progression Free Survival
研究概览
简要总结
This is an international, randomized, open-label, controlled, multicenter phase II clinical trial to investigate and compare the safety and efficacy of palbociclib combined with fulvestrant or letrozole in women with ER+, HER2- locally advanced or metastatic breast cancer.
详细描述
Patients will be stratified by site of disease (visceral vs. non-visceral) and by onset of metastatic disease diagnose (patients metastatic de novo versus non de novo).
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- Female
- 接受健康志愿者
- 否
入选标准
- •Women 18 years or older with metastatic or locally advanced disease, not amenable to curative therapy
- •Confirmed diagnosis of HR+/HER2- breast cancer
- •Post-menopausal status
- •No prior chemotherapy line in the metastatic setting
- •Measurable disease defined by RECIST version 1.1, or non-measurable disease
- •Eastern Cooperative Oncology Group (ECOG) PS 0-1
- •Adequate organ and marrow function, resolution of all toxic effects of prior therapy or surgical procedures
- •Resolution of all acute toxic effects of prior anti-cancer therapy or surgical procedures to NCICTCAE version 4.0 Grade equal or minor than 1
排除标准
- •ER or HER2 unknown disease
- •HER2 positive disease based on local laboratory results
- •Locally advanced breast cancer candidate for a radical treatment
- •Prior (neo)adjuvant endocrine treatment with DFI ≤ 12-months from completion of treatment.
- •Patients with rapidly progressive visceral disease or visceral crisis.
- •Major surgery within 4 weeks of start of study drug
- •Patients with an active, bleeding diathesis
- •Serious concomitant systemic disorder incompatible with the study
- •Are unable to swallow tablets
- •Chronic daily treatment with corticosteroids with a dose of ≥ 10mg/day methylprednisolone equivalent
- •Known active uncontrolled or symptomatic CNS metastases
- •Known hypersensitivity to letrozole, fulvestrant or any of their excipients, or to any PD-0332991 excipients
- •QTc > 480 msec on basal assessments, personal history of long or short QT syndrome, Brugada syndrome or known history of QTc prolongation, or Torsade de Pointes
- •Uncontrolled electrolyte disorders that can compound the effects of a QTc-prolonging drug
研究组 & 干预措施
Arm A
Active Comparator
Combination of Palbociclib and Letrozole
干预措施: Palbociclib (Drug)
Arm A
Active Comparator
Combination of Palbociclib and Letrozole
干预措施: Letrozole (Drug)
Arm B
Experimental
Combination of Palbociclib and Fulvestrant
干预措施: Palbociclib (Drug)
Arm B
Experimental
Combination of Palbociclib and Fulvestrant
干预措施: Fulvestrant (Drug)
结局指标
主要结局
1-year Progression Free Survival
时间窗: One year
Percentage of patients who are alive and without evidence of tumor progression (defined using RECIST v1.1)
次要结局
- Number of Participants With Grade 3/4 Adverse Events, SAEs, Deaths and Discontinuations •(Through study completion. From baseline up to 51 months.)
- Time To Progression (TTP)(Through study completion. From baseline up to 51 months.)
- Overall Survival (OS)(Through study completion. From baseline up to 51 months.)
- Clinical Benefit Rate(Through study completion. From baseline up to 51 months.)
- Overall Response Rate(Through study completion. From baseline up to 51 months.)
研究者
研究点 (2)
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