Phase 1/2 Open-Label Trial Of Sutent (Sunitinib Malate) And Aromasin(Exemestane) In The First-Line Treatment Of Hormone Receptor-Positive Metastatic Breast Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
To assess progression-free survival at the combination dose determined in the Phase 1 portion of the study, and safety of sunitinib combined with exemestane in patients with metastatic or locally-recurrent, unresectable breast cancer.
详细描述
The trial was terminated prematurely on August 28, 2008 due to the inability to recruit the planned number of subjects in order to provide meaningful efficacy data. There were no safety concerns regarding the study in the decision to terminate the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •At least 18 years of age
- •Estrogen and/or progesterone receptor positive adenocarcinoma of the breast with evidence of 1) unresectable 2)locally recurrent, or 3) metastatic disease
- •Postmenopausal
- •ECOG [Eastern Cooperative Oncology Group] </=1
- •Evaluable(e.g bone only disease allowed) and Measurable disease [RECIST (Response Evaluation Criterion in Solid Tumors)]
排除标准
- •HER2 [Human Epidermal Growth factor Receptor 2] positive disease not previously treated with herceptin
- •Any prior anti-angiogenic therapy, endocrine or cytotoxic anti-cancer therapy in the metastatic disease setting
- •Radiation therapy within 2 weeks of first study treatment
研究组 & 干预措施
A
sunitinib + exemestane
干预措施: exemestane (Drug)
A
sunitinib + exemestane
干预措施: sunitinib malate (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: From start of treatment until Day 1 of every other cycle (8 weeks) or death
PFS was defined as the time from enrollment to first documentation of objective tumor progression or to death on study due to any cause, whichever occurred first. If tumor progression data included more than 1 date, the first date was used. PFS was to be calculated as (first event date - the date of enrollment +1)/7.
次要结局
- Overall Response (OR) According to the Response Evaluation Criteria in Solid Tumors (RECIST)(From start of treatment until Day 1 of every other cycle (8 weeks))
- Duration of Response (DR)(From start of treatment until Day 1 of every other cycle (8 weeks) or death due to cancer)
- Overall Survival (OS)(From start of study treatment until death)
- Time to Tumor Progression (TTP)(From start of treatment until Day 1 of every other cycle (8 weeks))
- Clinical Benefit Rate (CBR)(From start of treatment until Day 1 of every other cycle (8 weeks))