NCT01068704已完成2 期
An Open-Label Randomized, Parallel, Two-Arm Phase II Study Comparing BMS-690514 + Letrozole With Lapatinib + Letrozole in Recurrent and Metastatic Breast Cancer Patients Who Are Hormone Receptor Positive Despite HER2 Status And Who Relapsed While Receiving or After Completing Adjuvant Antiendocrine Therapy
Bristol-Myers Squibb5 个研究点 分布在 2 个国家目标入组 4 人开始时间: 2010年6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
- 4
- 试验地点
- 5
- 主要终点
- Clinical Benefit Rate defined as percentage of subjects with a complete response, partial response, or stable disease for at least 6 months
研究概览
简要总结
The purpose of this study is to determine if BMS-690514 + letrozole will be more effective than lapatinib + letrozole in patients who have metastatic hormone receptor positive breast cancer after developing progressive disease immediately following adjuvant antiendocrine therapy
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
- •Documented invasive breast cancer
- •Greater than 10% tumor cells positive for estrogen receptor and/or progesterone receptor
- •HER2+ and HER2- (Human Epidermal growth factor Receptor) disease
- •Rapid disease progression despite treatment with tamoxifen, anastrozole or exemestane
- •ECOG Performance status = 0 or 1
排除标准
- •Prior hormonal therapy for metastatic disease
- •Prior hormonal therapy with letrozole for adjuvant disease
- •Symptomatic brain metastases
- •Prior treatment with any tyrosine kinase inhibitor
研究组 & 干预措施
Lapatinib + Letrozole
Active Comparator
干预措施: Letrozole (Drug)
BMS-690514 + Letrozole
Active Comparator
干预措施: BMS-690514 (Drug)
BMS-690514 + Letrozole
Active Comparator
干预措施: Letrozole (Drug)
Lapatinib + Letrozole
Active Comparator
干预措施: Lapatinib (Drug)
结局指标
主要结局
Clinical Benefit Rate defined as percentage of subjects with a complete response, partial response, or stable disease for at least 6 months
时间窗: Every 8 weeks according to CT scan
次要结局
- Objective Response Rate: defined as percentage of subjects with 'complete response' or 'partial response'(Every 8 weeks)
- Progression Free Survival: defined as time to disease progression(Every 8 weeks)
- Frequency and severity of adverse events in all subjects(Every 4 weeks)
研究者
研究点 (5)
Loading locations...
相似试验
已完成
3 期
A Study of Palbociclib (PD-0332991) + Letrozole vs. Letrozole For 1st Line Treatment Of Postmenopausal Women With ER+/HER2- Advanced Breast Cancer (PALOMA-2)Breast NeoplasmsNCT01740427Pfizer666
已完成
3 期
A Study Of Palbociclib (PD-0332991) + Letrozole VS. Placebo+ Letrozole For 1st Line Treatment Of Asian Postmenopausal Women With ER+/HER2- Advanced Breast Cancer [PALOMA-4]Breast NeoplasmsNCT02297438Pfizer340
进行中（未招募）
3 期
Study of PF-07220060 With Letrozole in Adults With HR-positive HER2-negative Breast Cancer Who Have Not Received Anticancer Treatment for Advanced/Metastatic DiseaseBreast CancerNCT06760637Pfizer1,035
已完成
2 期
Randomized Phase II Trial of Letrozole With or Without Dasatinib as First and Second-line Treatment for Hormone Receptor-positive, HER2-negative Post-menopausal Breast Cancer That is Unresectable, Locally Recurrent or MetastaticMetastatic Breast CancerNCT00696072Bristol-Myers Squibb120
已完成
4 期
RCT of Fixed vs Titrated Letrozole in Breast Cancer Patient Undergoing IVFBreast CancerInfertilityNCT01035099Weill Medical College of Cornell University41