Prospective Validation of Genomic Signatures to Predict Treatment Response in the Axillary Nodes After Neoadjuvant Chemotherapy in Patients With HER2-negative Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 277
- 试验地点
- 1
- 主要终点
- Probability of achieving a negative axillary nodal status
研究概览
简要总结
A genomic test was developed to predict chemo-sensitivity to taxane-anthracycline-based chemotherapy as neoadjuvant treatment. The primary aim of this study is to prospectively evaluate the microarray-based, genomic test as a predictor of axillary lymph node response. Also, to determine whether the probability of achieving negative axillary nodes, is sufficiently high for patients whose breast cancer is predicted to be chemo-sensitive to support omitting axillary dissection.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Clinical status of lymph nodes must be available
- •Sonographical status of lymph nodes must be available
- •Patients must consent to documentation of cancer treatment
- •Histologic diagnosis of invasive breast cancer, clinical stage T1-4, M0 (non-inflammatory T4c)
- •Patients scheduled for neoadjuvant chemotherapy
- •Treatment with a 3-weekly FEC or AC regimen (3-4 cycles) followed by 3-4 cycles of q3 weekly docetaxel or paclitaxel.
- •Local HER2 status of tumor biopsy must be negative.
排除标准
- •The patient has a prior history of invasive or metastatic breast cancer.
- •The patient had prior excisional biopsy of the primary invasive breast cancer.
- •The patient had prior ipsilateral sentinel axillary lymph node biopsy for breast cancer.
- •The patient cannot safely or feasibly undergo biopsy of the primary tumor.
- •The patient has a diagnosis of Stage IV (distant metastatic) breast cancer.
- •The patient has proven HER2-positive breast cancer, defined as a pathology report of amplification of the gene or 3+ score for immunohistochemical staining.
结局指标
主要结局
Probability of achieving a negative axillary nodal status
时间窗: at time of surgery
The overall rate of pathologic lymph node-negative status (pLN0) will be evaluated, including clinically lymph node-negative (cLN-) and lymph node-positive (cLN+) patients. For sample size calculation we will consider the rate of nodal conversion from clinically node-positive (cLN+) before treatment to pathologic node-negative (pLN0) after the completion of neoadjuvant chemotherapy. Patients who are clinically node positive (cLN+) will be evaluated for nodal response, i.e. conversion to pLN0 status. We assume that 30% of these patients will be predicted by the genomic predictor as responders (i.e. pLN0 status) after neoadjuvant chemotherapy, and that 70% of them will actually achieve pLN0 status. The study will be sized to have 80% power to detect observed response (pLN-negative) rates \> 50% in cLN-positive patients after neoadjuvant chemotherapy at a 95% confidence level (one sided). Probability will be measured in percent.
次要结局
未报告次要终点
研究者
Peintinger Florentia, MD
Professor
Medical University of Graz