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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 5
- 主要终点
- Number of Participants Experiencing in Situ Anti-tumor Effect of Tarceva
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Tarceva
干预措施: erlotinib hydrochloride (Drug)
Tarceva
干预措施: TUNEL assay (Genetic)
Tarceva
干预措施: protein expression analysis (Genetic)
Tarceva
干预措施: immunohistochemistry staining method (Other)
Tarceva
干预措施: laboratory biomarker analysis (Other)
Tarceva
干预措施: liquid chromatography (Other)
Tarceva
干预措施: mass spectrometry (Other)
Tarceva
干预措施: matrix-assisted laser desorption ionization mass spectrometry (Other)
Tarceva
干预措施: therapeutic conventional surgery (Procedure)
结局指标
主要结局
Number of Participants Experiencing in Situ Anti-tumor Effect of Tarceva
时间窗: 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.
次要结局
- Molecular Profile of Participants Who Are Responsive to Tarceva(at 5-14 days)
- Average Post-treatment Plasma Level of Erlotinib Hydrochloride(After last dose of Tarceva, at 5-14 days, and before surgery)
研究者
Carlos L. Arteaga
Professor of Medicine and Cancer Biology, Associate Director of Clinical Research, Director VICC Breast Program, Medical Oncologist
Vanderbilt-Ingram Cancer Center