Using Clinicopathomic Markers to Predict Neoadjuvant Chemotherapy Response in Breast Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Pathologic complete response (pCR)
研究概览
简要总结
This study examines retrospective clinical data on patients diagnosed with breast cancer and monitor their response to neoadjuvant chemotherapy, incidence of locoregional recurrence, distant metastasis, and disease-free survival. The hypothesis of this study is that breast cancer patients who achieve a pathological complete response (pCR) to neoadjuvant chemotherapy demonstrate distinct clinicopathomic biomarker signatures.
详细描述
The specific aims of the study are to (1) to identify clinicopathomic biomarkers from pre-treatment core biopsies that are predictive of response to neoadjuvant chemotherapy, (2) determine patterns of metastasis from primary breast cancer to other distant sites, (3) determine the rates of local recurrence in breast cancer patients, and (4) to determine if there are significant radiomic, pathomic, and clinical markers for recurrence and distant metastasis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Participants must be men and women age 18+
- •Biopsy-confirmed diagnosis of invasive breast cancer; (ER+/-, PR+/-, HER2+/-)
- •Any state of disease as described by AJCC v7 criteria
- •Participants must have received and completed neoadjuvant chemotherapy
排除标准
- •Participants who had other primary cancers prior to breast cancer
结局指标
主要结局
Pathologic complete response (pCR)
时间窗: Up to 60 months
Evaluating the degree of absence of residual cancer cells
次要结局
- Time to local breast recurrence(Up to 60 months)
- Time to distant metastasis (months)(Up to 60 months)
- Time to death(Up to 60 months)
研究者
Dr. William Tran
Radiation Therapist Clinician Scientist
Sunnybrook Health Sciences Centre