Feasibility, Validation and Implementation of Genomic Testing for Chemotherapy and Endocrine Sensitivity of HER2 Negative Primary Invasive Breast Cancer (Clinical Stage I to III)
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,100
- 试验地点
- 1
- 主要终点
- Feasibility defined as the ability to classify patients into 1 of 4 cohorts
研究概览
简要总结
This phase II trial studies how well genetic testing works in predicting tumor response in patients with stage I-III HER2 negative invasive breast cancer. Genetic testing is a procedure that tests tumor samples to learn if certain genes are activated (turned on) in the tumor and if the activation of these genes may predict if the tumor will be sensitive or resistant to routine breast cancer treatments, such as chemotherapy or hormonal therapy.
详细描述
PRIMARY OBJECTIVE:
I. To determine the feasibility of implementation of molecular (genomic) predictive testing for patients with localized (stage I-III) invasive carcinoma of the breast who are candidates for either adjuvant or neoadjuvant treatment of their breast cancer.
SECONDARY OBJECTIVES:
I. Estimate the frequency of tumors in each of the four molecularly defined cohorts, overall and within subsets defined by nodal status and estrogen receptor (ER) status.
II. Estimate the concordance of genomic analysis of gene expression levels for ER and HER2 from the microarray (published previously), compared with standard testing with immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) to determine ER and HER2 status in these tumors.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •The patient can undergo biopsy or surgery of a primary tumor site for suspected or proven invasive breast cancer of clinical stage I to III; stage IV patients will be allowed and included in the feasibility assessment, but will not be included in outcomes analysis for secondary objectives
- •The clinical or radiologic primary tumor size is at least 1 cm diameter
排除标准
- •The patient has proven HER2-positive breast cancer, defined as a pathology report of amplification of the gene or 3+ score for immunohistochemical staining
- •The patient has received prior systemic therapy or radiation therapy for breast cancer
- •The patient has a prior history of invasive or metastatic cancer within 5 years of diagnosis of breast cancer, excluding squamous cell or basal cell carcinoma of the skin
- •The patient had prior excisional biopsy of the primary invasive breast cancer
- •There is hematoma or biopsy site changes that obscure the primary tumor
- •Patients deemed medically ineligible for any adjuvant or neoadjuvant therapy. Patients with ER-positive (+) tumors deemed medically eligible for hormonal therapy, but not chemotherapy will be considered eligible for this protocol. Patients with ER-negative (-) tumors who are not candidates for adjuvant anthracycline based chemotherapy will be considered ineligible for this protocol. Patients who undergo biopsy and are later found to be ineligible for adjuvant therapy will be assessed for the primary objective, but will be excluded from the secondary objectives
研究组 & 干预措施
Diagnostic (biopsy, surgery, genetic testing)
Patients undergo biopsy or surgery to obtain tumor sample for genetic testing. Patients are then assigned to 4 treatment cohorts as determined by genetic test results.
干预措施: Biopsy (Procedure)
Diagnostic (biopsy, surgery, genetic testing)
Patients undergo biopsy or surgery to obtain tumor sample for genetic testing. Patients are then assigned to 4 treatment cohorts as determined by genetic test results.
干预措施: Conventional Surgery (Procedure)
Diagnostic (biopsy, surgery, genetic testing)
Patients undergo biopsy or surgery to obtain tumor sample for genetic testing. Patients are then assigned to 4 treatment cohorts as determined by genetic test results.
干预措施: Genetic Testing (Other)
结局指标
主要结局
Feasibility defined as the ability to classify patients into 1 of 4 cohorts
时间窗: Up to 5 years
The study will use the methods of Thall et al. to monitor the ability to classify patients into 1 of 4 groups (success rate) throughout the trial. Will use summary statistics to describe the demographic and clinical characteristics of patients overall and within each subgroup (Groups A-D).
次要结局
- Concordance of genomic analysis with immunohistochemistry (IHC)(Up to 5 years)
- Frequency of tumors(Up to 5 years)
- Disease-free survival (DFS)(Time between diagnostic tumor biopsy and the first failure event, assessed at 3 and 5 years)
- Indeterminate Results(Up to 5 years)