Genomic Markers for Measuring Breast Cancer Response to Neoadjuvant Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Pathologic complete response (pCR)
研究概览
简要总结
The primary aim of the study is to identify genomic markers (circulating tumor cells (CTCs), circulating tumor DNA (ctDNA), transcriptomic markers) as biomarkers of response to neoadjuvant chemotherapy (NAC) among patients with invasive breast cancer.
详细描述
The study aims to evaluate genetic markers (i.e. CTCs and ctDNA) in breast tumors to predict therapy response and metastatic risk. We aim to investigate genomic markers of treatment response and outcomes in breast cancer patients treated with neoadjuvant chemotherapy. The role of CTCs and ctDNA in predicting response to NAC will also be investigated.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must give appropriate written informed consent prior to participation in the study.
- •Subjects must be women or men age 18+.
- •Subjects must be receiving neoadjuvant chemotherapy for breast cancer. All chemotherapy types and regimens are acceptable (systemic therapy will determined by the overseeing medical oncologist).
- •Biopsy-confirmed diagnosis of invasive breast cancer (i.e. ER+/-, PR+/-, HER2+/-).
- •Stage I-III disease according to the AJCC v7 criteria.
排除标准
- •Subjects with a past medical history of abnormalities, significant injury, or medical or surgical procedures (e.g. silicone/saline implants) involving either breast, exclusive of the lesion at issue.
- •Subjects, who, in the opinion of the investigator or clinical research coordinator, may not otherwise be appropriate for inclusion into the study, such as significant anxiety.
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 distant breast cancer recurrence (months)(Up to 60 months)
- Time to any recurrence (months)(Up to 60 months)
- Time to death(Up to 60 months)
研究者
Dr. Katarzyna Jerzak
Medical Oncologist & Associate Scientist
Sunnybrook Health Sciences Centre