Erlotinib in Treating Patients With Breast Cancer That Can Be Removed by Surgery
Phase II Trial of OSI-774 (Tarceva), a Human Epidermal Growth Factor (HER) (erbB, Also Known as Epidermal Growth Factor Receptor, EGFR) Tyrosine Kinase Inhibitor, in Treatment-Naïve Operable Breast Cancer
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving erlotinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase II trial is studying how well erlotinib works in treating patients with breast cancer that can be removed by surgery.
研究概览
地位
条件
干预/治疗
详细说明
OBJECTIVES:
Primary
- To determine the in situ antitumor effect of neoadjuvant erlotinib hydrochloride as measured by a reduction in Ki67 and/or an increase in terminal deoxynucleotidyl transferase-mediated deoxyuridine triphosphate-biotin nick end labeling (TUNEL)-positive tumor cells in patients with treatment-naive, operable breast cancer.
Secondary
- To identify a molecular profile, based on measurements of Estrogen Receptor (ER), Epidermal Growth Factor Receptor (EGFR), and a Human Epithelial Growth Factor Receptor-2(HER2), and protein expression profiles in patients with treatment-naïve, operable breast cancer that is responsive to erlotinib hydrochloride.
- To correlate tumor concentrations of erlotinib hydrochloride with serum levels immediately before surgery.
OUTLINE: This is a multi-center study.
Patients receive oral erlotinib hydrochloride once daily for 5-14 days. Patients then undergo surgical resection within 24 hours after the last dose of erlotinib hydrochloride.
Tumor tissue samples are collected at baseline and during surgery for correlative laboratory studies. Tissue samples are stained for ER, HER2, and EGFR levels, proliferation (Ki67), and apoptosis (TUNEL) by immunohistochemistry. Levels of erlotinib hydrochloride in tissue samples are measured by matrix-assisted laser desorption/ionization mass spectrometry. Blood samples are collected on the day of surgery. Levels of erlotinib hydrochloride in blood samples are measured by liquid chromatography/mass spectrometry.
Patients are followed within 6 weeks after surgery.
研究类型
注册 (实际的)
阶段
- 阶段2
联系人和位置
学习地点
-
-
Alabama
-
Birmingham、Alabama、美国、35249
- University of Alabama, Birmingham
-
-
Massachusetts
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Boston、Massachusetts、美国、02115
- Dana-Farber Cancer Institute
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North Carolina
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Chapel Hill、North Carolina、美国、27514
- Lineberger Comprehensive Cancer Center
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Tennessee
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Nashville、Tennessee、美国、37232
- Vanderbilt-Ingram Cancer Center
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Nashville、Tennessee、美国、37208
- Meharry Medical College
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
Clinical stage I or II (T1 or T2, N0 or N1) invasive mammary carcinoma
Diagnosis may be made by fine needle aspiration cytology or core biopsy
- A repeat core biopsy is not required for patients who have a paraffin embedded diagnostic core biopsy specimen available for immunohistochemical staining
Exclusion Criteria:
Patients with locally advanced disease who are planning to undergo preoperative neoadjuvant therapy are not eligible*
Locally advanced disease includes any of the following:
- Primary tumor ≥ 5 cm (T3)
- Tumor of any size with direct extension to the chest wall or skin (T4a-c)
- Inflammatory breast cancer (T4d)
- Fixed axillary lymph node metastases (N2)
- Metastasis to ipsilateral internal mammary node (N3) NOTE: *Patients with primary tumors ≥ 5 cm (T3) or tumors involving the chest wall or skin who are not candidates for preoperative chemotherapy or who decline preoperative chemotherapy are eligible
Measurable residual tumor at the primary site
- Measurable disease is defined as any mass that can be reproducibly measured by physical examination
- Planning to undergo surgical treatment with either segmental resection or total mastectomy
- Patients with a prior history of contralateral breast cancer are eligible if they have no evidence of recurrence of their initial primary breast cancer
- No locally recurrent breast cancer
- No evidence of distant metastatic disease (i.e., lung, liver, bone, or brain metastases)
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Menopausal status not specified
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- ANC ≥ 1,000/mm^3
- Creatinine ≤ 1.5 times upper limit of normal (ULN)
- Total bilirubin ≤ 1.5 times ULN
- Serum glutamic oxaloacetic transminase (SGOT) and serum glutamic pyruvic transminase (SGPT) ≤ 1.5 times ULN
- Must be at least 18 years old
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No serious medical illness that, in the judgement of the treating physician, places the patient at high risk of operative mortality
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior chemotherapy for this primary breast cancer
- At least 7 days since prior tamoxifen or raloxifene as a preventive agent
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Tarceva
|
Tarceva will be given orally at a dose of 150 mg/day for 5-14 days.
Patients are to undergo surgical resection of their tumor within 24 hours of the last dose of Tarceva.
其他名称:
Used to assess drug-induced changes in tumor cell proliferation and cell death in pre-therapy and surgical specimens
Used to assess drug-induced changes in tumor cell proliferation and cell death in pre-therapy and surgical specimens
Used to assess drug-induced changes in tumor cell proliferation and cell death in pre-therapy and surgical specimens
Used to assess level of expression of genetic markers in pre-therapy and surgical specimens
Used to determine blood plasma levels of Erlotinib on the day of surgery
其他名称:
Used to determine blood plasma levels of Erlotinib on the day of surgery
其他名称:
After treatment and following surgery, intervention will be used to determine Tarceva levels in tissue
其他名称:
Surgical treatment will occur within 24-hours following completion of therapy.
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Number of Participants Experiencing in Situ Anti-tumor Effect of Tarceva
大体时间:5-14 days
|
In situ anti-tumor effect of Tarceva as measured by a minimum 75% reduction in Ki67 compared to pre-treatment tumor cells in patients with operable breast cancer.
|
5-14 days
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Molecular Profile of Participants Who Are Responsive to Tarceva
大体时间:at 5-14 days
|
Determined by estrogen receptor status (ER) and human epidermal growth factor receptor 2 (HER2) status, which are measured by staining of 200-500 tumor cells and noting the number stained.
Positive = > 10% of cell show staining, negative = < 10% of cells show staining
|
at 5-14 days
|
Average Post-treatment Plasma Level of Erlotinib Hydrochloride
大体时间:After last dose of Tarceva, at 5-14 days, and before surgery
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Post-treatment plasma level in µmol/L of erlotinib hydrochloride
|
After last dose of Tarceva, at 5-14 days, and before surgery
|
合作者和调查者
调查人员
- 学习椅:Carlos L. Arteaga, MD、Vanderbilt-Ingram Cancer Center
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
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