A Phase II Trial of Letrozole Plus OSI-774 (Tarceva) in Post-menopausal Women With ER and/or PR-Positive Metastatic Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 48
- 试验地点
- 9
- 主要终点
- Number of Patients With Pathological Complete Response.
研究概览
简要总结
RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using letrozole may fight breast cancer by blocking the use of estrogen by the tumor cells. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving letrozole together with erlotinib may kill more tumor cells.
PURPOSE: This phase II clinical trial is studying how well giving letrozole together with erlotinib works in treating postmenopausal women with estrogen receptor-positive and/or progesterone receptor-positive locally recurrent or metastatic breast cancer.
详细描述
OBJECTIVES:
Primary
- To determine the rate of clinical benefit (complete response [CR], partial response [PR], and stable disease [SD] in patients with hormone-dependent locally recurrent or metastatic breast cancer treated with letrozole in combination with erlotinib hydrochloride.
Secondary
- To determine the time to progression (TTP) in patients treated with this regimen.
- To evaluate the anti-tumor activity, as determined by CR and PR rates, of this regimen in these patients.
- To evaluate the safety of this regimen in these patients.
- To determine if tumors that are positive for epidermal growth factor receptor (EGFR) or Ser118 ER, or that overexpress human epidermal receptor (HER2) exhibit a longer TTP from the combination compared to tumors that do not express or overexpress these molecules.
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
- Female
- 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
Second-line/prev hormone-therapy tx
干预措施: fluorescence in situ hybridization (Genetic)
First line/hormone-therapy naive
干预措施: erlotinib hydrochloride (Drug)
First line/hormone-therapy naive
干预措施: letrozole (Drug)
First line/hormone-therapy naive
干预措施: fluorescence in situ hybridization (Genetic)
First line/hormone-therapy naive
干预措施: immunohistochemistry staining method (Other)
First line/hormone-therapy naive
干预措施: laboratory biomarker analysis (Other)
Second-line/prev hormone-therapy tx
干预措施: erlotinib hydrochloride (Drug)
Second-line/prev hormone-therapy tx
干预措施: letrozole (Drug)
Second-line/prev hormone-therapy tx
干预措施: immunohistochemistry staining method (Other)
Second-line/prev hormone-therapy tx
干预措施: laboratory biomarker analysis (Other)
结局指标
主要结局
Number of Patients With Pathological Complete Response.
时间窗: at 24 weeks
Per RECIST criteria v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) \> 30% decrease in the sum of the longest diameter (LD) of target lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions
次要结局
- Median Time to Progression of Target Lesions(Every 12 weeks from on-study to disease progression)
- Number of Patients With Anti-tumor Activity: Complete Response (CR) and Partial Response (PR)(at 24 weeks)
- Number of Patients With Worst-grade Toxicities Per Grade(at 24 weeks)
研究者
Ingrid Mayer, MD
Assistant Professor of Medicine; Clinical Director, Breast Cancer Program; Medical Oncologist
Vanderbilt-Ingram Cancer Center