TME Neoadjuvant Breast Registry (The NEAT Registry)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,000
- 试验地点
- 4
- 主要终点
- Pathologic response and/or endocrine sensitivity
研究概览
简要总结
Prospective observational registry that links results of the genomic and other molecular testing to treatment response and survival measures in patients who have been diagnosed with breast cancer and who are targeted for neo-adjuvant therapy. Analysis includes how tests impact treatment decisions and outcomes.
详细描述
Physicians will order tests on patients as part of standard of care; they will report whether test results influenced: selection between standard therapies or a clinical trial; offered insight into mid therapy treatment changes; or helped physicians determine what therapy to offer patients who do not have a complete pathologic response. Patient demographics, diagnosis, type of treatment, surgery and pathologic results will be recorded. Patients will be followed for 5 years. Recurrence and survival data will be recorded.
Participating sites will submit de-identified patient data via electronic case report forms (eCRFs) into a secure study website.
All patients are required to sign an Informed Consent Form. All investigators and staff will have Human Subject Protection Training.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with histologically proven invasive breast cancer who have started or are scheduled to start neo-adjuvant chemotherapy or endocrine therapy
- •Ages 18-90
- •Written informed consent
排除标准
- •Patients who have had excisional biopsy or axillary dissection
- •Patients with confirmed metastatic disease
- •Patients who have had recent chemotherapy
结局指标
主要结局
Pathologic response and/or endocrine sensitivity
时间窗: Post surgical treatment--usually within 4 months
次要结局
- Metastasis-free/relapse-free survival in molecular subgroups(5 years)